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Federal Regulation of Methadone Treatment (1995)

Chapter: Treatment Standards and Optimal Treatment

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Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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7
Treatment Standards and Optimal Treatment

As discussed in chapter 1, the rationale for government policy in opiate addiction treatment, in the view of the committee, flows from concerns for the functioning of individual addicts, the minimization of public health risks, and the reduction of criminal behavior associated with drug abuse, as well as the minimization of methadone diversion consistent with these objectives.

Although the Secretary of Health and Human Services is obligated under the law to set standards for narcotic addiction treatment, and the federal methadone regulations have been the sole means for implementing this requirement historically. The committee views one major purpose of standards to be improving the quality of treatment. In this chapter, we consider how standards should be implemented to improve treatment.

We begin by discussing the definition of terms, we then consider the characteristics of good treatment with respect to patient evaluation and admission, maintenance pharmacotherapy, medically supervised withdrawal, inpatient treatment, and pain management. As the discussion of our topics unfolds, we have occasion to refer to the barriers to effective treatment and suggest specific changes that should be made in the current regulations to remove or minimize these barriers. Throughout, we distinguish between methadone as a medicine and methadone maintenance treatment as a program of comprehensive services that enhance the effectiveness of the pharmacological treatment.

The detailed discussion in this chapter of treatment in relation to the federal methadone regulations stems from the view of the committee that regulations have an appropriate place, but that they can be improved in a number of ways. Moreover, improvements lie in the direction of reducing governmental involvement in the regulation of treatment services and relying more on the judgment of clinicians, aided by the development of clinical practice guidelines.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

The implementation of standards by regulations is not, in fact, required by the statute. Nonetheless, the regulations have been relied on to prescribe standards which have discouraged the development of alternative or complementary approaches. Chapter 8, therefore, deals with the role of federal regulations in improving treatment, as well as other ways to implement standards, such as clinical practice guidelines and formal quality assurance systems, and with issues of federal government leadership.

Definition of Terms

The following definitions are put forward to clarify certain important concepts. Tolerance is the condition resulting from continued use of an opiate drug (or of any substance) that makes it necessary to use increasing amounts of the drug to produce the desired effect. Physical dependence is the condition resulting from repeated administration of a drug that necessitates its continued use to prevent the unpleasant withdrawal syndrome that occurs when the drug is abruptly discontinued. Although physical dependence is associated with tolerance, the latter can occur without causing physical dependence. Addiction is a condition characterized by lack of control and compulsion that lead to illicit or inappropriate drug-seeking behavior. It can occur with or without physical dependence. An opiate agonist is a drug that mimics the effects of endorphin, a naturally occurring compound, thus producing an opiate effect by interaction with the opioid receptor site. Examples are morphine, heroin, and methadone. An opiate antagonist is a drug that displaces any opiate agonists and binds with the opioid receptor, thereby inhibiting the opiate effect of the agonist drug. An example is naloxone or naltrexone (Trexan), which prevents or reverses the effects of heroin by competitive binding at the receptor site. Opiate agonist pharmacotherapy refers to therapy based on a drug action that mimics the effects of another opiate drug. An example is the therapeutic use of methadone, an opiate agonist used to treat opiate addiction. Opiate antagonist pharmacotherapy involves the use of a drug that inhibits or prevents the effects of opiate agonist drugs. An example is the therapeutic use of naltrexone to block the effects of heroin or other opiate agonist drugs.

The two primary clinical applications of opiate agonist pharmacotherapy to treat opiate addiction are the limited-term withdrawal of an addict from opiate use with the objective of achieving abstinence from illicit opiates and other psychoactive substances (known as detoxification treatment) and chronic administration of medication for chronic opiate addiction (known as maintenance treatment).

These terms—''detoxification treatment" and "methadone maintenance treatment"—raise several issues. "Detoxification" has posed the most difficulty.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

In the 1950s, at the Lexington Public Health Hospital, methadone was used as a way to ''detoxify" heroin addicts by substituting methadone for heroin, then tapering the dose to zero to minimize withdrawal symptoms. The term "detoxification" entered the regulations in 1972 and was incorporated into the Narcotic Addict Treatment Act (NATA) in 1974. The term has been used historically to mean the use of methadone to terminate opiate use through the reduction of the methadone dose, and then to terminate methadone use as well.

Current regulations, based on the NATA, specify short-term (up to 30 days) and long-term (31 to 180 days) detoxification treatment. The original 1972 regulations limited detoxification to 21 days and made no distinction between short and long-term. Three problems exist with these arbitrarily defined treatment periods. First, they bear no documented relationship to scientific or clinical data. Rather, they are based on a philosophic commitment to a drug-free state that ignores such data. Second, they arbitrarily constrain treatment decisions by clinicians. Third, treatment based on these artificial time limits often results in the patient relapsing to illicit opiate use. "Such" limits defeat the ultimate purpose that detoxification treatment was designed to serve, namely, of using methadone to withdraw from both the use of illegal opiates, such as heroin, and from continued reliance on methadone itself.

Clinical experience of more than two decades has thus shown repeatedly that linking treatment to these predetermined time periods for "detoxification" does not help chronically relapsing opiate-dependent patients to recover from their addiction. Rather, these arbitrary periods may actually hinder recovery by encouraging treatment decisions based on nonclinical, administrative grounds. For example, because patients admitted for "detoxification" represent a short-term obligation of treatment programs, by definition, they often receive fewer services than patients admitted for maintenance, without respect to clinical need. Not surprisingly, the results of detoxification treatment have been generally disappointing. High rates of relapse to drug use and abuse have been a frequent correlate of detoxification treatment (Lipton and Maranda, 1981; Resnik, 1983. The steady lengthening of the permissible treatment period over time and the differentiation of detoxification into short- and long-term treatment is tacit recognition by the government of these disappointing results.

Therefore, the committee recommends that "medically supervised withdrawal (MSW)" be substituted for "detoxification" and be defined as follows: "Acute or short-term (several days, several weeks, or a few months) administration of an approved, long-acting opiate agonist drug to an individual patient, at a steadily reduced dose on a schedule and rate such that the individual is able to continue to function with a tolerable level of discomfort and the use of short-acting opiates by the individual is discouraged."

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

With respect to the term "methadone maintenance treatment," the committee also proposes that the definition of the sustained use of methadone to treat opiate addiction in the regulations be modified to describe the treatment more accurately.

Specifically, the committee recommends that "maintenance pharmacotherapy (MPT)" be substituted for "methadone maintenance" (at Sec. 291.505(a)(2)) of the regulations and be defined as follows: "Sustained administration of an approved opiate agonist drug, at relatively stable doses, for the treatment of opiate addiction."

In addition, the committee proposes that the following language changes be made in the regulations and incorporated in any practice guidelines that are developed later:

Replace all references to the treatment of "narcotic addicts" with references to the treatment of "opiate addiction"; replace all references to "narcotic dependence" with ''opiate addiction"; and replace all references to ''opiate addict" with the definition of "opiate addiction." "Opiate" defines the class of drug in question; "narcotic" refers to any stupor-inducing drug, and is a legal term that includes cocaine (see chapter 5). "Addiction" is to be distinguished from "dependence."

Replace the term "continuous or sustained use of a narcotic drug" (at Sec. 291.505 (a)(1)), and wherever it is used which could refer to pain patients, with the term "addiction to opiates."

Eliminate the definition of "narcotic dependent" (Sec. 291.505(a)(5)), which fails to define the class of drugs and could be confused with physical dependence on non-opiate drugs.

Replace the term "narcotic treatment program" (Sec. 291.505(a)(6)), with the term "opiate addiction treatment program." Narcotic is an inappropriate adjective for "treatment program," and the greater specificity of the latter term is desirable.

Replace all references to the treatment of "narcotic addicts with a narcotic drug" with references to the treatment of "opiate addiction with an opiate." The greater specificity of the latter terms is desirable.

Replace all references to the term "physiological dependence" with the term "physical dependence" and eliminate any use of "dependence" as a synonym for "addiction." "Physical" has a clear meaning; "physiological" does not change the meaning but does not add clarity. "Dependence" and "addiction" are to be distinguished; the former can occur without the latter.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

Patient Evaluation and Admission Criteria

The evaluation of patients for admission to treatment is relatively simple at the two ends of the spectrum defined by long-term methadone maintenance and detoxification. Opiate addicts whose addiction has persisted over many years and who have a history of multiple relapses should typically be admitted to maintenance treatment. Individuals with only a brief history of opiate use (of a few weeks or months) who have developed tolerance and physical dependence and cannot stop use on their own are likely candidates for detoxification.

The cases that do not fall clearly in either category pose the greatest challenge to the clinician. When the assessment of a candidate patient is not immediately clear, evaluation and admission decisions should be made by well-trained clinicians in consultation with the patient. The current federal methadone regulations do not help the clinical assessment of patients. Rather, they specify formulas, such as minimum standards for admission, which have no clinical relevance for determining which patients are eligible for maintenance and which for detoxification.

In general, the decision to admit a patient to methadone pharmacotherapy, either medically supervised withdrawal,(MSW) or maintenance pharmacotherapy (MPT), should be based on a comprehensive evaluation and a clear clinical diagnosis of physical opiate dependence and chronic opiate addiction, defined to include the psycho-social-behavioral characteristics described as "drug-seeking behavior." A comprehensive evaluation should establish patient eligibility for methadone pharmacotherapy on the basis of the following: current physical opiate dependence and addiction; objective findings and subjective reports of the patient that support the need for pharmacotherapy; a judgment that the patient is capable of understanding and participating in a treatment program; and an expressed willingness of the patient to enter treatment after the nature of that treatment has been carefully explained to him or her.

Once a primary diagnosis of opiate addiction has been made, an assessment of its duration and severity should determine the most appropriate treatment for the patient. The decision to treat should consider all available treatments, including nonpharmacological interventions.

The initial assessment must also address the other medical and psychosocial needs of prospective patients needs. These are likely to be considerable in the case of candidates for MPT, since most such patients have diverse and often severe medical and psychological needs that require attention independently of the addiction treatment decision.

It is essential to obtain informed patient consent to treatment at the initiation of treatment and again when the patient is stabilized. Obtaining

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

consent should include a thorough explanation of clinic rules and procedures and the patient's acknowledgment that these have been explained and understood. Patient consent should be periodically reviewed.

Admission to Medically Supervised Withdrawal

The determination of who should be placed on MSW is based on whether the individual has an acute or chronic addiction, is or is not eligible for MPT, and prefers MSW to MPT. The patients for whom MSW is appropriate are the following:

  1. An individual diagnosed as having acute opiate addiction and who is ineligible for MPT. Although ineligible for MPT, the patient prefers MSW to an arbitrarily defined detoxification schedule or to no treatment at all.
  2. A chronic opiate addict who wishes to terminate the illicit use of opiates but does not wish to begin a program of MPT, even though he or she may meet the eligibility criteria for MPT, even though he or she may meet the eligibility criteria for MPT.
  3. A chronic opiate addict who has experienced the adverse effects of too rapid a reduction of methadone dose under an arbitrarily defined detoxification schedule, and who may have relapsed to the use of illicit opiates, and who wishes to withdraw from methadone use at a slower, less disruptive pace.
  4. An MPT patient who wishes to withdraw from methadone use, whose dose may be tapered off on an individualized basis as he or she continues MPT.
  5. Patients living in areas where MPT is not available, and who may have to be put on MSW by default.

Individual patient assessments should determine what elements of comprehensive treatment should be in the patient's treatment plan. Although the treatment plan will change to reflect changes in the patient's clinical situation, it should be recognized that the probably shorter-term MSW patient may require more, not less, intensive and comprehensive care than the longer-term MPT patient.

Admission to Maintenance Pharmacotherapy

Admission to methadone maintenance treatment was originally limited to the "hard-core heroin addict," defined as a person with a year or more of daily self-administration of heroin. Current regulations still draw the line at an

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

addiction history of at least one year duration. The intensity, severity, and course of the addiction history, however, must also be considered in the diagnosis, and not only the literal "history" based on dates provided by an applicant, who is often suffering from withdrawal during the initial interview. In some cases, an individual with as little as six months of heavy heroin use may be diagnosed as chronically opiate-dependent, even though a period of addiction closer to twelve months is needed in most cases.

MPT should be reserved for the chronic cases of opiate addiction, as determined by the full array of clinical diagnostic criteria discussed above (pp. 8–9). The basis for requiring that admission be limited to chronic opiate addiction is that long-term exposure to opiates, including medications such as methadone and LAAM, may result in the adaptation or alteration of some neurobiological function. The patient with chronic opiate addiction is likely to have experienced this process of adaptation or alteration already.

Other factors that should be considered by clinicians in the decision to begin MPT, in addition to current physical dependence on opiates and length of opiate use, include currently approved exceptions in the regulations, such as patients with history of chronic opiate addiction (pregnant women, those recently released from correctional or chronic care facilities, and former MPT patients at risk of relapse).

Proper Patient Placement

Admission to MPT should generally be limited to patients with opiate addiction. Unfortunately, a single clear definition of opiate addiction does not exist. Clinicians working in the field of addiction medicine are clear that opiate physical dependence alone does not equal opiate addiction. In addition to opiate physical dependence, addiction requires loss of control resulting in continued use of opiates despite adverse consequences. Loss of control may be characterized as illicit or inappropriate drug-seeking behavior, even in the absence of pain or withdrawal.

Some members of the committee are concerned that distinctions between opiate addiction and opiate physical dependence may not be adequate to prevent inappropriate admissions to long-term MPT. For example, chronic pain patients who become physically dependent on opiates and then experience withdrawal symptoms when opiates are reduced or discontinued are sometimes referred, inappropriately, to methadone treatment programs which treat opiate addiction.

The pain patient, whose remission of pain allows discontinuance of opiates, often requires treatment for opiate withdrawal symptoms. However, these patients usually manifest no compulsion or drug-seeking behavior. The

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

treatment of pain patients who do not have a diagnosis or history of opiate addiction in the setting of a program designed for the treatment of opiate addiction is rarely appropriate. Such pain patients are more appropriately managed in the pain clinic or in a physician's office. On the other hand, some methadone treatment programs may be well-equipped to deal with pain patients, especially those located in hospitals.

Two Conclusions

The committee draws two conclusions from the above discussion about patient evaluations. First, the assessment of opiate addiction should be based on clinical diagnostic criteria and should not be determined by formulas set forth in regulations. Second, the diagnostic criteria for MPT should be set forth in clinical practice guidelines, such as the CSAT State Methadone Treatment Guidelines (see, e.g., Center for Substance Abuse Treatment, 1992) or the American Society of Addiction Medicine criteria, (see ASAM, 1991). Such guidelines should indicate the level of training and competence that is desirable for clinicians in treatment programs authorized to make such a diagnosis.

Therefore, the IOM committee recommends that the regulations acknowledge the importance of the clinical evaluation of patients and minimize the administrative criteria in the maintenance pharmacotherapy admission decision by (1) noting that opiate physical dependence alone is not sufficient grounds for recommending MPT; (2) substituting "medically supervised withdrawal (MSW)" for "detoxification" and substituting ''maintenance pharmacotherapy (MPT)" for "methadone maintenance"; and (3) removing all language that encourages or discourages either MSW or MPT on the basis of nonclinical criteria (e.g., admission criteria that include arbitrary time frames.)

Maintenance Pharmacotherapy

Effective maintenance treatment for individual patients involves two elements—the provision of an appropriate dose of medication and a range of comprehensive services. The level of each of these elements is expected to change as a function of time in treatment and the patient's needs. We deal first with dosing principles, then with comprehensive services. In addition, we discuss take-home medication and urine testing. Implications for regulation are

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

then examined, followed by a concluding subsection on addiction in pregnant women.

Dosing

The goals for pharmacotherapy of addiction to opiates include the following: the prevention or reduction of withdrawal symptoms, the prevention or reduction of drug craving, the prevention of relapse to use of such drugs, and, when possible, the restoration or movement toward normality of any physiological functions disrupted by chronic drug abuse (Kreek, 1992). Effective opiate pharmacotherapy (methadone or LAAM) is achieved by a dosage level that establishes a "steady-state" occupation of adequate numbers of specific opioid receptors.

Dosing can be divided into phases (Payte and Khuri, 1992), which are indicated on Table 7-1. The committee concludes that dosing practices should not be determined by regulations but instead should be based on current scientific and clinical knowledge and on published guidelines, where feasible. What that knowledge tells us is:

  1. Patients tend to vary in level of opioid tolerance and dependence as well as in the absorption, metabolism, and elimination of methadone. Hence it is essential to determine each dose individually, taking patient reports seriously and monitoring the patient's reaction to medication carefully. In the patient with established tolerance to opiates the initial dose of methadone is usually 20 to 40 mg. The purpose of the initial and first few doses is to relieve withdrawal signs and symptoms that are present. The dose required to accomplish this purpose varies according to the level of tolerance and dependence. A single dose of methadone reaches a blood level peak between 2 and 4 hours. It is prudent to wait at least 3–4 hours before additional doses of methadone are provided and important that patients be observed closely in the induction period at the initiation of treatment. Abstinence symptoms may appear before the end of this initial, 24-hour dosing interval, because there has been no accumulation of methadone in the liver and other tissues to sustain steady drug levels in the circulation. Therefore, additional small doses of methadone (5–20 mg) may be needed three to twelve hours after the initial dose, for up to one week, to prevent signs and symptoms of opiate withdrawal (Dole et al., 1966; Kreek, 1991c; Payte and Khuri, 1992).
  2. After initial dosing, the goal is to achieve full prevention of both signs and symptoms of withdrawal for 24 hours. The 24-hour period requires that a steady-state level be established, which may require 5–10 days. Assessment of the effectiveness of dose in the first few days is best determined by the res-
Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

TABLE 7-1 Principles of Methadone Pharmacotherapy Dosing

Phase

Purpose

Dose (range, mg)

Initial dose

Relieve withdrawal symptoms

20–40 in tolerant patients

Early induction

Bring dose to established tolerance level

5–10 mg every 3-24 hours

Late induction

Assure adequacy of dose; "blockade"

+/- 5–10 mg every 7 days

Maintenance/Stabilization

Achieve goals listed above

60–120 mg, could be more, or less

Long-term maintenance or medical maintenance

Maintain stability and physiologic normalcy

60–120 mg

Medically supervised withdrawal

Gradual reduction of tolerance to zero

Variable, reductions of 10% of dose level every 7–10 days (as tolerated)

  1. ponse at 10–12 hours after the dose, rather than at 24 hours. Early in treatment, the patient may need more time on the same dose of methadone rather than a larger dose of methadone. After initial stabilization, daily doses of methadone are then gradually increased, by 5 or 10 mg each week, until a full treatment dose of 60 to 120 mg is reached by the end of an induction period of four to eight weeks.
  2. In addition to prevention of the withdrawal syndrome, the dose should reduce or eliminate drug hunger or craving. Given the substantial availability of opiates in the environment of many patients, those individuals who may be vulnerable to the opportunistic use of opiates should have their dose gradually raised to a "blockade" level. The resulting cross-tolerance will ensure that supplemental opiates will not produce the desired effect. For most patients the "blockade" level will be between 60 and 120 mg daily. Some patients do well on less than 60 mg and others may require more than 120 mg (Dole, 1989; Inturrisi and Verebey, 1972; Kreek, 1973; Loimer, Schmit, et al., 1991).
Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×
  1. Determining methadone blood levels is seldom necessary but may be helpful to ensure adequate patient dosing in those situations where patients experience problems on doses that are usually in the therapeutic range. Blood levels should remain at levels greater than 150 ng/ml. An optimum level of methadone will be based on a clinical judgment of the ability of the patient to abstain from heroin and other opiates, and the comfort level of the patient. Optimal individual doses are more likely in the 400 ng/ml range. It is recommended that blood be collected at 3–4 hours and again at 24 hours after an observed dose (Payte and Khuri, 1992). The rate of elimination is as important as the actual levels. The peak should be no more than twice that of the trough level. Rapid metabolizers may benefit from split doses. (See chapter 2.)
  2. Stable maintenance doses may require adjustments from time to time. The vast majority of dose determinations can be based purely on clinical signs and symptoms. Subjective reports of the patients must be heeded as it is not realistic to rely solely on objective evidence for dose adjustments, especially when a patient is experiencing drug hunger or cravings. At the same time, the clinician must be alert to the occasional patient who wants a higher dose than necessary in order to sell a portion of it "on the street."
  3. Pregnant patients are managed by the same principles but with some special considerations (see below).

In light of the above, the committee recommends that the regulations retain the language that "the amount of the initial dose should not exceed 30 mg" in order to protect the safety of the newly admitted methadone patient. Other dosing restrictions should be removed from the regulations, including the language that "the administering physician shall ensure that a daily dose greater than 100 mg is justified in the patient record"; patient take-home medication and other clinic privileges should not be contingent on dose levels, and clinical practice guidelines should be developed to assist clinicians regarding adequate dosing and take-home practices.

Comprehensive Treatment Services

Methadone as a medication is but one element of a comprehensive treatment program offering a full range of services, which include methadone administration, counseling, and other medical care (Hubbard et al., 1989; McLellan et al., 1993; TOPS 1979–1981).

The premise of this argument is that the overriding goal of MPT is to habilitate (to make capable, to qualify) and rehabilitate (to return to a former capacity, healthy condition, or useful function) patients with opiate problems

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

to a basic level of social, life, work, and health capabilities that help them become productive, independent members of society.

Opiate-dependent patients typically have a range of medical, psychological, economic, legal, and social problems. For example, studies by Rounsaville et al. (1982), Khantzian and Treece (1985) and Woody et al. (1983) have documented the high proportion of psychiatric diagnoses seen in methadone-maintained patients. Ball and Nurco, among others, have shown very high rates of individual and property crime among opiate-dependent patients. Metzger and Platt (1988) have shown the extreme problems of unemployment and deficits in job-seeking skills among a significant proportion of these patients. Studies by Stanton and his colleagues (Stantan, 1979; Stanton et al., 1992) have documented the serious family and relationship problems found in opiate-dependent patients maintained on methadone. Finally, the problems of AIDS, hepatitis, tuberculosis, and other infectious diseases are widely documented and growing rapidly among opiate-dependent patients.

It is important to note that these problems, rather than opiate use itself, are the major sources of concern to society. These "associated problems" are not only a source of substantial direct expense to the country but are in turn associated indirectly with the apparent deterioration in the quality of life for many areas of the country. Thus, while methadone maintenance can be seen as a service to or even a privilege for the affected individual because it reduces his/her withdrawal symptoms and cravings for opiates, to the extent that it is effective in reducing the social harm caused by these associated problems, methadone maintenance treatment may be seen as a public health benefit to society, similar to education and vaccination programs. It must be emphasized that the potential benefits to the public derive from reductions in the associated problems of crime, loss of productivity, and disproportionate use of medical and social services for those in methadone treatment—and not from reductions in the use of opiates per se.

Although these associated problems occur disproportionately among opiate-abusing patients, there has been debate about their origins and the appropriate role of methadone maintenance treatment in addressing them. If these additional problems were due entirely or even predominantly to the use of opiates, and if the methadone medication by itself were effective in eliminating opiate use, then the provision of methadone alone would likely be effective both in reducing the target problem of opiate use and in bringing about the larger social goals of rehabilitation. It is well documented that methadone in adequate doses, by itself, can produce marked reductions in illicit opiate use (Yancovitz, Des Jarlais, et al., 1991; McLellan, Woody, et al., 1988). Further, it seems clear that these reductions in illicit opiate use as well as the accompanying stabilization of craving is a necessary precondition for achieving any additional rehabilitation.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

Current practice in most methadone maintenance programs includes, at best, an evaluation of a newly admitted patient's medical and psychosocial treatment problems, followed by assignment to a paraprofessional "counselor," who often has a 50-patient caseload. During the course of treatment over succeeding weeks and even years, the counselor—not professionally trained physicians, social workers, or pscyhotherapists—is typically the only treatment provider available to or seen by the patient. Even patients with very serious medical, social and psychiatric problems often receive no more than the usual paraprofessional, drug-focused counseling during methadone treatment. Such counseling is a form of advice and general support, usually delivered by an individuals with substantial field experience but rarely having advanced training in social work, psychology, nursing, or medicine. The major focus of drug counseling is on monitoring drug use by reviewing urinalysis reports, monitoring problematic behaviors, encouraging compliance with clinic rules, helping to resolve acute social or personal crises, encouraging patients to seek and maintain gainful employment, providing (where possible) liaison services with physicians, courts, and social agencies, and encouraging patients to talk about important personal or family problems.

Several studies document the efficacy of this form of treatment service for the "average" methadone-maintained patient. At the same time, this mainstay of methadone maintenance treatment is frequently in short supply due to large patient caseloads (current regulations allow for caseloads of 50 patients per counselor). More importantly, it is clear from numerous studies that patients with more severe medical, psychiatric, employment, housing, and legal problems are not adequately served by drug counseling alone. There is accumulating evidence that even adequate doses of methadone, in the absence of additional counseling and medical and social services, produce suboptimal reductions in opiate use and have only minimal effects on reducing other drug and/or alcohol problems of these patients or solving their health, economic, crime, and medical problems that are so important to society (McLellan, Woody, et al., 1988; Ball and Ross, 1991).

Further, it is clear that the presence of these associated problems significantly affects the course and overall results of treatment (Hubbard and Marsden, 1986; Sells, Demarre, et al., 1986; McLellan, Luborsky, et al., 1982; McLellan, Luborsky, et al., 1986). Patients in methadone maintenance who have had little improvement in their employment, family, and psychiatric problems will be in greater danger of relapse.

Over the past 10 years numerous investigations have evaluated the benefits obtained by adding professional interventions to basic methadone maintenance. For example, in an initial investigation of the "active ingredients" of treatments McLellan et al. (1988) evaluated the contribution of drug counseling services to overall outcome from methadone maintenance. The drug counselor

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

assignment was found to be a particularly significant aspect of methadone maintenance treatment. Woody et al. (Woody, McLellan, et al., 1987; Woody, McLellan, et al., 1984) have shown the benefits of adding professional psychotherapy to methadone maintenance, while Metzger and Platt have shown similar benefits from adding employment and skills training.

A more recent study of different levels of services within a methadone maintenance treatment program goes directly to the question of the minimal conditions necessary for social rehabilitation and the effects of adding counseling and other services to methadone maintenance (McLellan, Woody, et al., 1988). In that study three groups of voluntary patients were randomly assigned at the beginning of their methadone maintenance treatment to receive different types and amounts of treatment services. All patients received initial physical examinations, laboratory testing, and a short program of AIDS education. Thereafter, level one patients received methadone maintenance (blocking doses of 60 mg. or more) without additional counseling except in an emergency basis. Level two patients received the same methadone stabilization plus regular counseling by a trained rehabilitation specialist, but no additional services. Level three patients received the same services as level two patients, but in addition were also provided family therapy, employment, counseling, and regular medical and psychiatric care on an as-needed basis at the methadone program site.

There were significant differences in the amounts of improvement shown across these three levels. Patients in Level One showed some improvement in their opiate use but not in their cocaine use or in any of their other problems. They also showed minor improvements in employment, but no other changes. The simple addition of a counselor to this level of services (ie. Level Two) was associated with enhanced improvement in many problem areas, but adding services of family therapists, physicians and social workers for Level Three patients produced still greater changes, particularly among the most severely impaired patients. In summary, this work indicates that counseling and especially professional interventions should be added to standard methadone treatment and these interventions can produce significant improvements in drug use, employment, legal status, and health services utilization in individuals with multiple problems.

Three conclusions flow from existing research on the rehabilitative goals of methadone maintenance treatment. First, the available national data indicate that opiate-dependent patients at the time of treatment admission typically show a wide range of serious health and social problems in addition to their primary problem of opiate dependence.

Second, data from three decades of controlled clinical trials and field research indicate that these opiate-dependent patients show improvement in, if not elimination of, their opiate addiction with the provision of adequate doses

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

of methadone. This improvement, in turn, tends to result in reductions in opiate-related crime and in the direct effects of opiate use such as needle sharing (e.g., in transmission of AIDS and other infectious diseases).

Third, improvements in the important social and self-support areas are at least in part related to the types and amounts of counseling and other professional medical and social services provided during treatment. There is little evidence that, at least at the initiation of methadone treatment, the provision of methadone by itself can lead to reductions in other important problem areas of non-opiate drug use, alcohol dependence, unemployment, psychiatric problems, and disproportionate use of health care services. Data from the past ten years have shown that counseling and particularly professional health care and social services can significantly augment the direct effects of methadone in achieving reductions in opiate use and are essential to achieving the important goals of social rehabilitation for opiate-dependent patients.

Take-Home Medication

The committee discussed at length the issue of take-home medications. It concurs with existing federal regulations providing that ''take-home medicine may be given only to a patient who, in the reasonable judgment of the program physician, is responsible in handling narcotic drugs" (21 CFR 291.505(d)(6)(iv) (A)). The committee also believes that decisions about patient take-home medication should be made only by the medical director of the treatment program, and should be documented in the patient's medical chart.

The basis for clinical judgment should continue to be the following eight criteria currently set forth in the federal methadone regulations (see 21 CFR 291.505(d)(6)(iv)(B)): (1) absence of recent abuse of drugs (opiate and non-opiate), including alcohol; (2) regularity of clinic attendance; (3) absence of serious behavioral problems at the clinic; (4) absence of known recent criminal activity, e.g., drug dealing; (5) stability of the patient's home environment and social relationships; (6) length of time in maintenance treatment; (7) assurance that take-home medication can be safely stored within the patient's home; and (8) whether the rehabilitative benefit to the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion. Clinician decisions should be documented relative to each of these criteria.

A majority of the committee believes that the current regulations are too restrictive regarding the schedule of clinic treatment visits required before take-home medication can be administered and in the maximum permissible take-home supply. They would prefer that regulations read as follows: In the first month of treatment there should be six clinic treatment visits a week, and

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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maximum take-home supply should be limited to a single day; in the second month, there should be at least three clinic treatment visits a week, with a maximum take-home supply of two days; in the third month, patients should visit the clinic for treatment at least twice a week, and be eligible for a maximum take-home supply of three days; in the remaining months of the first year, clinic treatment visits should be weekly at least, with a maximum take-home supply of seven days; after one year, a patient should be eligible for medical maintenance, involving monthly visits and a maximum take-home supply of 31 days. The rationale for this take-home schedule is to permit treatment plans to be tailored more closely to the needs of the individual patient, facilitate the entry into treatment of patients who may be more functional than those "last resort" patients who constitute the great majority of the treated population, and vest more authority for clinical decisions in clinicians.

A minority of the committee, though sympathetic to the above objectives, is reluctant to replace the existing regulations with a more flexible set of rules and to recommend changes designed for the "best" patients and most scrupulous clinicians, which, if adopted, would become the standard for all. The rationale for retaining existing regulations is to pace the progress of patients in relation to reasonable expectations, to minimize opportunity for malpractice by unscrupulous physicians, and to maintain the credibility of treatment programs that could easily suffer from the behavior of a few such individuals.

Urine Testing

Federal regulations now require treatment programs to conduct urine tests of methadone patients at admission, plus a minimum of eight times in the initial year, and quarterly thereafter, except for patients receiving a six-day take-home supply, who must be tested monthly. The committee accepts this requirement as a minimum. State authorities and individual treatment programs sometimes impose stricter urine testing requirements than these.

Urine testing is a helpful clinical tool, useful as a way to determine patient progress and compliance with treatment protocols. It should be used in conjunction with other clinical tools, never as a sole indicator of action.

Implications for Regulations

The above conclusions regarding the habilitation and rehabilitation of patients in methadone and other opiate substitution therapies support

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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recognition and acceptance of the proposition that the full potential of methadone maintenance as a significant public health service to society will be realized only if it is financially and professionally supported to the point at which it can offer necessary habilitative and rehabilitative services. Both a scientific evaluation of existing treatment programs (Woody, et al., 1983; Hubbard and Marsden, 1986) and a inspection of national media stories about methadone make it apparent that the present system of care offered by methadone maintenance programs has deteriorated badly over the past ten to fifteen years while the number, chronicity, and complexity of the problems presented by the patients have increased (e.g., AIDS, TB, cocaine, crime). At this point, the best that is available to even seriously impaired opiate-dependent patients in methadone maintenance is the availability of paraprofessional drug counseling. While important and necessary, it is clear that drug counseling alone (especially when compromised by caseloads of 50 patients) is not sufficient to address the serious problems of medical illness, psychopathology, dangerous or inadequate living situations and lack of self-support skills, so often presented by these patients. The committee believes that a full range of medical, psychiatric, and social services is needed to achieve the optimal benefits of MPT treatment.

Although the committee believes that additional treatment services are cost-effective, it recognizes that many treatment programs are not now providing them. Moreover, a requirement that they be provided could very well impose an economic burden on many treatment programs that would force them to cease providing services altogether. The committee notes that the fiscal year 1995 budget submission and the recently-enacted urine bill future may result in increased future resources for treatment (see chapter 8). It urges the responsible federal agencies to monitor the flow of funds to treatment programs and to require that comprehensive services be provided as available resources are increased.

Given adequate financial support, regulations could specify that MPT programs provide the following services toward the goal of realizing the full potential of such programs to produce public benefits:

  1. Perform a comprehensive evaluation of the full range of medical, employment, alcohol, criminal, and psychological problems of all patients admitted to methadone maintenance and medically supervised withdrawal. As indicated above, it is in the public interest for methadone maintenance programs to address the "addiction related" problems of unemployment, crime, and infectious diseases. If these problems are to be addressed effectively, they will have to be evaluated and addressed in the initial treatment plan for all patients.
Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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  1. Offer screening for diseases such as AIDS, tuberculosis, hepatitis, and sexually transmitted diseases on-site or nearby. These diseases are disproportionately represented in the opiate-abusing population and represent a risk to all society as well as to the individuals directly affected. Typically, few medical screening services are available to these patients outside the methadone maintenance programs and it is in the interests of the patient, and of society, to see that these diseases are recognized and treated.
  2. Offer on-site counseling by competent and appropriately supervised addiction counselors. It is not clear at this time how much counseling is needed for patients entering treatment or for how long. The majority of patients entering treatment, however, will require several sessions of counseling each week during the first months of stabilization, and this level of counseling intensity should be available as a standard part of MPT. It is also unclear whether a particular set of qualifications is required to optimize counseling efficacy and how individuals can be trained to become effective counselors. At the same time, effective counseling can be evaluated and encouraged through ongoing supervision. Thus experienced professional supervision of counseling staff should be a regular part of MPT.
  3. Offer professional medical, social work, and mental health services, preferably on-site or by referral (through contracted interagency agreements). These services should not be considered ''frills," but rather necessary components for MPT programs to achieve the public benefits that justify their existence. Not all patients will need all of these professional services, but the recognition of those who do need the services will be one of the duties of the admission assessment and the ongoing counseling. It may not be possible or even cost-effective for every program to have on-site professionals representing all the services that will potentially be needed by these patients.

Two points are relevant here, however. First, it has been historically difficult to connect opiate-dependent patients with the services that they so clearly need, even when these services are available. There are problems with motivation, disorganization, discrimination, distrust, and confusion that prevent patients from accessing these services even in the best of conditions. In addition, there are many well-documented incidents in which professional services were denied to methadone-maintained patients merely because of the stigma associated with their condition.

When referrals to other treatment sites are required, it is seldom adequate to provide only a written or telephone referral to the other agency. Effective provision of needed services on a referral basis will usually require contractual arrangements between agencies, close working arrangements between responsible individuals at the programs and agencies, and active follow-up by the referring program to insure that services are delivered.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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Therefore, the committee recommends that those services that are most clearly needed by admitted patients (e.g., medical and social work) should be provided on-site by competent, licensed, and appropriately supervised professionals wherever possible and, if necessary, by contractual referral arrangements.

This recommendation can only be put in place when MPT programs are restored to a level of funding and professionalism commensurate with the severity of the disorder(s) toward which they are directed. Without infusion of both financial and professional support, any changes in the regulations will be ineffective in increasing the potential benefit of this therapy.

Opiate Addiction in Pregnant Women

The use of methadone to treat pregnant opiate addicts has, for years, been controversial. Although the benefits of methadone pharmacotherapy in pregnancy, in contrast to continued illicit drug use, have been clearly demonstrated, some issues remain unresolved. Studies are complicated by a multitude of confounding variables (Finnegan, 1991). Nevertheless, the following conclusions can be drawn these studies with respect to methadone pharmacotherapy in perinatal addiction:

  1. Comprehensive MPT (LAAM is not yet approved for use in pregnant women), when combined with appropriate prenatal care, can reduce the incidence of obstetrical and fetal complications, in utero growth retardation, and neonatal morbidity and mortality (Finnegan, 1991; Kaltenbach, et al., 1992).
  2. There is no reported evidence of any toxic effects of methadone in the woman, fetus, or child, although such evidence has been sought.
  3. Withdrawal from methadone treatment is rarely appropriate during pregnancy (Finnegan, 1991; American Society of Addiction Medicine, 1991). Relapse to opiate use occurs in these individuals in the same way as in nonpregnant addicts (Finnegan, 1991).
  4. Neonatal withdrawal syndrome may occur in methadone-exposed neonates. Treatment protocols are available to assist in appropriate management (Finnegan, 1986; Finnegan, 1990).
  5. Increased doses of methadone may be needed during the late stages of pregnancy. Methadone metabolism increases in some pregnant women, thus decreasing the methadone levels in their blood; an individualized dose increase may then be needed to maintain constant plasma levels and prevent symptoms of withdrawal (Kaltenbach, et al., 1992). There is no consistent correlation
Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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  1. between maternal methadone dose and severity of neonatal withdrawal (Stimmel, et al., 1982–1983).
  2. Breast feeding may be encouraged during methadone pharmacotherapy, if not otherwise contraindicated (Kaltenbach, 1992).
  3. Multiple longitudinal studies find that methadone-exposed infants score well within normal range of development (Kaltenbach, 1992; Kaltenbach and Finnegan, 1984).
  4. Obstacles and barriers to methadone pharmacotherapy for pregnant women with opiate addiction (such as lack of financial resources, waiting lists, procedural delays of admission for treatment, or lack of knowledge about how to treat pregnant opiate addicts safely and humanely), must be removed. Pregnant opiate-addicted women need immediate access to methadone treatment services. Limitations in the federal regulations, along with waiting lists for treatment or geographic inaccessibility, create barriers for the safe and effective treatment of this population.
  5. More research is needed on innovative models of treatment, including medically supervised withdrawal during pregnancy with residential care, intensive relapse prevention and monitoring, and high-risk prenatal care. When appropriate, hospitals, clinics, and individual obstetricians should be permitted to administer methadone to a pregnant opiate addict in collaboration with a licensed MPT program.

In light of the above discussion, the committee recommends that regulations (1) require that programs establish rapid admission procedures to facilitate prompt treatment for pregnant opiate addicts; (2) assure alternative ways to provide maintenance treatment for pregnant opiate addicts where treatment is not otherwise available; and (3) allow providers to give maintenance pharmacotherapy outside of a licensed narcotic treatment program. Alternatives to treatment programs might include hospital, pharmacy, clinic, and individual practitioner's office acting as MPT programs for the purpose of prescribing methadone to pregnant opiate addicts who are awaiting admission into a licensed program, or for the duration of the pregnancy for patients in geographic areas where there are no licensed programs. In such cases, the determination of dosage, the treatment plan, and the acceptable time of treatment after conclusion of the pregnancy should be made in consultation with addiction treatment experts and should operate according to specific guidelines for such patients.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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Medically Supervised Withdrawal

As a consequence of the limits of detoxification treatment, discussed earlier, the committee is proposing that the regulations be changed by eliminating the term "detoxification treatment" and replacing it with the term "medically supervised withdrawal." This section outlines the principles of medically supervised withdrawal (MSW), the goal of which is the gradual reduction of the methadone dose to zero at a tolerable rate that neither creates undue discomfort for the patient nor results in his or her relapse to illicit opiate use. Too high a dose serves more of a maintenance than withdrawal purpose; too low a dose impairs functioning and may lead to the substitution of other opiates or drugs, including alcohol.

The individuals for whom MSW is appropriate were indicated earlier in this chapter (see "Patient Evaluation and Admission Criteria"). The principles of long-term medically supervised MSW include the following:

  1. Any patient being considered for MSW must be physically dependent upon opiates and therefore have an established opiate tolerance level, which is determined by the amount of methadone required to suppress the signs and symptoms of withdrawal. For the MPT patient that level is roughly equal to the daily dose.

    Doses that may range slightly above or below the average tolerance level result in no subjective or objective reactions and define a "comfort zone" for the patient. This range is believed to be up to 10 percent +/- of dosage. Any dose reduction within the comfort zone will usually be well tolerated. Dosage and withdrawal schedules must be individualized and be the result of careful clinical judgment.

  2. When the dose is reduced within the comfort zone, the degree of tolerance begins to adjust to the new dose level over a period of several days. When the tolerance level equals the reduced dose, the process can be repeated. Intervals of 7–10 days are adequate for adjustment to a single-step reduction in most cases. However, some patients will tolerate more rapid reductions, while others will need additional time.
  3. The application of this dose reduction principle would result in MSW treatment lasting for years in some cases. Dose decrements of less than 1 mg are not practical useful. Many clinicians use decrements of 2, 2.5, or 5 mg, depending upon the form of methadone used as well as the tolerance level as reflected by the current average methadone dose.
  4. Successful MSW is not assured by simple avoidance of withdrawal syndrome. As the methadone is reduced, a point may be reached for some patients at which daily dose is inadequate to provide the desired level of steady-state occupation of adequate numbers of receptor sites, and symptoms
Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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  • such as drug craving may recur. Many experienced practitioners of methadone maintenance find that there is an individual methadone dosage in some patients, usually between 15 and 50 mg, at which the patient has considerable difficulty making further reductions.

Patients whose initial treatment is MSW and who then resume opiate use during withdrawal should be encouraged to stabilize themselves on methadone before resuming withdrawal. If appropriate, they may wish to consider initiation or resumption of MPT, instead of proceeding with withdrawal.

Individuals who have withdrawn from methadone under medical supervision should be carefully followed by a treatment program and encouraged to participate in an ongoing program of recovery. In the event of relapse or impending relapse, additional therapeutic measures should be used, including, when appropriate, the rapid resumption of agonist pharmacotherapy.

Under certain circumstances, MSW is initiated against a patient's will (e.g., given the certainty of discharge, the patient may elect MSW rather than pursue transfer to another program or facility). When withdrawal from methadone pharmacotherapy is not medically indicated, it is referred to as involuntary administrative withdrawal. The circumstances that justify involuntary administrative termination from treatment usually involve inappropriate behavior that threatens the program's welfare or jeopardizes the safety or health of patients and staff. Involuntary administrative withdrawal should be the course of last resort when it has been determined that methadone MPT (at the particular program) is no longer appropriate and when no alternative placement for the patient is possible. Transfer to another facility should be aggressively pursued (and documented in the patient's record) and is the preferred course for those patients for whom involuntary administrative discharge is indicated. Only if transfer is not possible, and all alternatives have been exhausted, should involuntary withdrawal commence, and it should be medically supervised.

The decision to terminate methadone maintenance treatment has profound implications for a patient and should not be implemented until the conclusion of a hearing and appeal. In cases of involuntary MSW, it is particularly important that the pace of the withdrawal be accomplished safely (according to standards set forth in this report) and as comfortably as possible in order to minimize the patient's chances for relapse to illicit substance abuse. In cases where a patient's immediate departure from the program is imminent, the patient should be transferred to another facility for involuntary MSW.

MSW patients who experience difficulties with small reductions in dose over considerable intervals of time should be considered for inpatient treatment, alternative or additional pharmacotherapy (clonidine, etc.), or in some cases early admission to maintenance pharmacotherapy. These decisions should be weighed carefully to determine the most appropriate action. Given

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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the risks of HIV, hepatitis, STDs, and TB, any decision that increases the likelihood that the patient will return to the use of street drugs must be taken seriously.

The outcome of MSW is more likely to depend on such factors as personal motivation, patient resources, support systems (especially family), and appropriate comprehensive treatment than on the number of days in the withdrawal schedule.

In light of the above, the committee recommends: (1) that the Narcotic Addict Treatment Act be amended, if necessary, and the regulations changed accordingly, to eliminate the term "detoxification treatment" and replace it with "medically supervised withdrawal (MSW)," [as defined in the "Definition of Terms'' section above]; (2) that no time limits be specified for MSW in the revised regulations; (3) that the revised regulations indicate clearly that MSW is not appropriate for all opiate addicts but is an essential treatment that should be available to all who wish such treatment or would benefit from it; and (4) that clinical practice guidelines, based on the above general principles, be developed to assist clinicians in the clinical management of MSW patients, including the determination of appropriate dose schedules for individual patients.

Recent years have seen increased utilization of non-opiate withdrawal regimens involving clonidine, available to methadone programs only under an Investigational New Drug (IND) protocol, and in some cases accelerated withdrawal using opiate antagonists. It is beyond the scope of this report to cover this material. The reader is referred to references (Senft, 1991; Brewer et al., 1988; Gossop, 1988; Kleber, et al., 1988) for more information.

Inpatient Treatment

The foregoing discussion has dealt with opiate-addicted patients treated in the outpatient setting. The federal regulations governing methadone treatment also affect opiate-addicted individuals in the inpatient setting: methadone maintenance patients who are hospitalized for medical or surgical reasons; and opiate addicted individuals not in treatment programs who are admitted for similar reasons.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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Maintenance Pharmacotherapy in Hospital Inpatient Settings

Methadone patients who are admitted to hospitals as inpatients, whether for addiction-related reasons or for unrelated medical and surgical reasons, often are mistreated and mismanaged by hospital staff (Payte and Khuri, 1992). Mistreatment may vary from negative attitudes toward the patients by hospital staff to punitive decisions to withhold methadone; mismanagement may involve failing to provide for the adequate treatment of pain (Zweben and Payte, 1990). Consequently, the committee concluded that some guidance to hospital staff is warranted.

Current regulations do not address the issues of inpatient MPT patients beyond providing a means for continued pharmacotherapy. (Most hospitals have a DEA registration, so they are not prohibited from providing methadone from their pharmacy stock.) These issues are most appropriately addressed by guidelines for hospital staff dealing with such patients. Guidelines, in the judgment of the committee, should reflect the following general principles:

  1. On admission of a methadone maintenance patient as a hospital inpatient, the hospital staff should notify the patient's treatment program and confirm the individual's enrollment in the treatment program, methadone dose, and time and date of last dose.
  2. During a methadone maintenance patient's inpatient stay, the hospital staff should ensure the continuity of methadone pharmacotherapy through the hospital's pharmacy or by making arrangement for its supply through the treatment program in the event the hospital does not stock methadone. Hospital staff and physicians should be prohibited from reducing or denying the methadone dose. Any changes in methadone pharmacotherapy should be made only after consultation with the treatment program physician and with the informed consent of the patient.
  3. Before discharge, the hospital staff should notify the methadone treatment program of the time of discharge and the time and amount of last dose of methadone to ensure that outpatient pharmacotherapy can be resumed without interruption.
  4. If patients are discharged from acute care to continuing care facilities, arrangements for continued provision of methadone should be part of the discharge plan.
  5. Inpatients with Untreated Opiate Addiction

    Currently, the federal methadone regulations restrict the use of methadone for treating opiate addiction to the following four situations: (1) a licensed "narcotic treatment program"; (2) a licensed, hospital-based, inpatient addiction

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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treatment unit for detoxification from opiate addiction; (3) a hospital, for temporary maintenance or detoxification, when the admission is for an illness other than opiate addiction; and (4) an outpatient setting (hospital, private practice, clinic, or nursing home with a medical director and 24-hour nursing care) in which methadone is administered daily for a maximum of 3 days while the patient awaits admission into a methadone treatment program. The only circumstance in which methadone can be routinely prescribed and administered on an outpatient basis outside of an officially registered "narcotic treatment program" is for the treatment of pain.

The above restrictions may on occasion result in precipitous withdrawal of opiate-addicted patients. Opiate-addicted patients admitted to hospitals with medical illness related or unrelated to illicit injecting drug use who are in need of methadone treatment pose particular problems. Two unfortunate scenarios can occur: (1) admitted methadone patients are not administered methadone for the relief of opiate withdrawal because detoxification would not be completed before discharge; or (2) opiate-addicted inpatients do receive methadone treatment, but are precipitously withdrawn from methadone at discharge because no arrangement have been made for their transfer to an outpatient treatment program or there are insufficient programs to accept them. Although it has been difficult to document accurately the length of waiting lists for methadone treatment programs, it is well-known in the treatment community that waiting lists exist, especially for those patients who do not have financial or insurance resources. Therefore, it is reasonable to assume that a significant number of patients who seek methadone treatment are unable to obtain access to services.

The committee recommends that the following change be made in the regulations to accommodate the needs of hospitalized opiate addicted patients: Patients who meet the criteria for opiate addiction during any inpatient hospital admission may be treated, when appropriate, with methadone to relieve opiate withdrawal. Patients may then be discharged to methadone treatment programs for their continued treatment. If no resources are available for the patient upon discharge, or if a patient is ready for discharge before his or her withdrawal protocol can be completed, a hospital may accommodate such patients by completing the withdrawal protocol on an outpatient basis. For a patient awaiting admission to a licensed "narcotic treatment program," the hospital may maintain the patient on a maintenance dose of methadone until the patient is admitted by the program. In either case, methadone must be administered daily at the facility by staff licensed to handle and administer opiates. Patients shall not be given prescriptions for methadone for this purpose.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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Pain Management

Methadone was approved by the FDA for the treatment of pain on August 13, 1947. As noted in chapter 1, its use in the treatment of opiate addiction has been highly regulated since late 1972. In the course of this study, the committee received communications from representatives of the pain management community indicating that the methadone regulations had created a number of problems, and much confusion, regarding the use of the drug in pain management. The regulations, intended for one purpose, had generated unanticipated, unintended, and undesirable consequences elsewhere.

Although not asked to deal specifically with issues of pain and its clinical management, the committee has concluded that the intersection of the two uses of methadone—for treating opiate addiction and for pain treatment—is of sufficient importance to warrant this discussion. We identify two issues: first, the problems of the non-opiate addicted pain patient; and second, those of the methadone maintenance patient and the "recovering" opiate-dependent patient who also needs pain treatment. Central to these issues is the need to distinguish the pain patient from the opiate-addicted patient.

Non-Opiate-Addicted Pain Patients

The pain patient with no evidence of addiction poses one set of challenges; the patient with opiate addiction and chronic pain, a different set. The important distinction to be made is that tolerance and physical dependence do not equal addiction (see chapter 2 and the section "Definition of Terms" above).

As a disease, addiction is chronic, progressive, relapsing, and often fatal, and it is characterized by compulsion and continued use of the substance despite adverse consequences (loss of control). The patient with opiate addiction will seek drugs in the absence of any pain or withdrawal symptoms.

The pain patient, on the other hand, will develop tolerance to a number of opioid effects and physical dependence on opiates but will not exhibit the illicit or inappropriate drug-seeking behavior. Nor will many pain patients, in the absence of progressive disease, develop tolerance to the analgesic effects of opioids. The typical pain patient who experiences a cure or remission of pain does not experience the compulsion to resume or continue drugs. Portnoy and Payne (1992) cite three studies: in one, of 11,882 inpatients with no prior history of addiction who were administered opiates, only four cases of psychological dependence could be documented; in the second, a survey of 10,000 burn patients, with no prior history of addiction, who were treated with

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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opiates identified no cases of addiction; in the third, of 2,369 pain patients who regularly used opiates for relief of headache, only three were addicted.

The treatment of pain and the treatment of opiate addiction may both involve the prescription of methadone. Beyond that, treatment should be totally distinct. For example, it may be appropriate to treat patients with both a chronic pain disorder and opiate addiction in clinics having well-trained staff, especially those that are an integral part of a hospital. However, it is not appropriate to treat a chronic pain patient as an opiate addict in a maintenance pharmacotherapy program, regardless of the degree of tolerance, physical dependence, or duration of the prescription of methadone. On the other hand, persons suffering from opiate addiction are unlikely to receive appropriate treatment in pain clinics and, as a general rule, should not be treated for addiction in such clinics. Those MPT patients who also have chronic pain conditions may require coordinated treatment in both clinical settings, which sometimes may exist within in a single organization.

The intensity of chronic or intractable pain cannot be measured objectively and, thus, physicians cannot determine clearly its authenticity. On the other hand, there are clear objective criteria for physical dependence. Physicians treating pain may lack the confidence to continue prescribing schedule II opiate analgesics in the absence of a very clear organic or anatomic basis for pain. The uneasy physician may then make an inappropriate referral to methadone pharmacotherapy.

Therefore, the IOM committee proposes that the regulations establish a clear distinction between opiate addiction and dependence and that any guidelines developed for methadone treatment incorporate this distinction. In addition, the committee recommends that the regulations prohibit the admission of a person being treated solely for chronic pain to an opiate addiction treatment program for treatment as an opiate addict.

As David E. Joranson, of the University of Wisconsin Pain Clinic, wrote to the committee (letter, October 25, 1993): "A person who needs a morphine-like drug only for the medical treatment of intractable pain and to prevent withdrawal associated with the treatment of intractable pain is not a narcotic addict and is not eligible for admission to a narcotic treatment program. A practitioner may prescribe, administer, or dispense narcotic drugs including methadone in the course of professional practice to such a person for the treatment of intractable pain."

It is appropriate that pain experienced by opiate-addicted individuals, along with other medical and psychiatric conditions, be treated in the context of a comprehensive methadone treatment program. Pain treatment centers, on the

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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other hand, are prohibited from and should not attempt treatment of opiate addiction involving any form of MPT, unless licensed and approved to do so. This prohibition should not prevent daily use of methadone at adequate doses for pain treatment as well as prevention of withdrawal symptoms.

Methadone Patients

The opiate-addicted patient with a chronic pain condition can challenge the treating clinician. Effective pain management may require an adequate maintenance dose of methadone as a foundation for pain treatment, but may also involve adequate doses of opiates other than methadone. Both conditions require specialized care.

Methadone-maintained patients who are being treated for conditions associated with acute moderate-to-severe pain are often denied treatment for pain. This denial is usually based on two misconceptions: first, that any patient taking a daily dose of methadone should derive adequate analgesia from the maintenance dose, and second, that prescribing an additional amount of an opiate agonist would lead to relapse and/or compromise the treatment of the addiction.

Opiate addiction treatment program medical staff must provide guidance to physicians, dentists, and other practitioners to ensure humane treatment of methadone-maintained patients being treated for acute pain. Three principles are involved:

  1. Continue methadone pharmacotherapy without interruption.
  2. Provide adequate doses of appropriate short-acting opiate agonist drugs for pain. Owing to cross-tolerance, higher than normal doses of short-acting opiate agonists will be required for relief of pain. Also, for adequate relief of pain, doses may be needed at more frequent intervals (Payte and Khuri, 1992).
  3. Antagonist and mixed agonist-antagonist opiate drugs are not to be given because they may produce a serious withdrawal reaction in opiate-tolerant individuals.

''Recovering" Opiate and Other Substance Dependent Patients

Recovering patients who experience acute pain and require opiate pain medication are perceived to be at some risk for relapse to substance abuse or addiction. Clinical experience suggests that such relapses occur more frequently when the patient fails to inform the attending physician(s) of an alcohol or other drug history. The risk is minimal in cases in which the

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
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clinician has some understanding of addictive disorders and the recovery process in relation to the treatment of pain. Honest communication between the patient and the physician is essential.

The minimal principles of management are:

  1. Provide adequate doses of appropriate short-acting opiate agonist drugs.
  2. Relief of pain is essential to avoid distrust and manipulation. Medicate generously for the first 24–48 hours for patients hospitalized for injury or surgery. Be thoughtful about PRN medication by anticipating pain where possible, rather than waiting for pain to manifest itself and then preparing medication, thus losing valuable time. Patient-controlled analgesia may be appropriate and effective if opiate tolerance levels are taken into consideration. Prescriptions offered on a specific schedule can be useful for many patients; a schedule avoids requiring the patient to ask for or to decide whether or not he or she needs medication.
  3. Change to non-opiate medication as soon as practical.
  4. Avoid extensive prescribing for self-administration of any opiate analgesic medications.

Concluding Comments

The federal methadone regulations have been very extensive and highly prescriptive about basically all aspects of treatment of opiate addiction. From 1972 to the present, these regulations have been modified in useful ways as their limiting effects on treatment have become apparent. However, these modifications, adopted in 1980, 1989, and 1993, have not seriously questioned the underlying assumptions of the original regulations.

The committee's recommendations in this chapter reflect the view that wholesale abandonment of the current regulations is neither feasible nor desirable. The regulations do serve some useful purposes, as indicated above. On the other hand, the recommendations propose to reducing the scope of administrative control by FDA and other DHHS agencies over methadone treatment programs. The corollary of reducing governmental discretion over treatment programs is to recommend that increased reliance be placed on clinical practice guidelines, as they are developed, for clinicians and treatment programs. This shift of responsibility from government officials to clinicians, is already under way in some measure and should be extended, as the committee has recommended.

Suggested Citation:"Treatment Standards and Optimal Treatment." Institute of Medicine. 1995. Federal Regulation of Methadone Treatment. Washington, DC: The National Academies Press. doi: 10.17226/4899.
×

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×

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For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.

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