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4 Treatment Setting and Effectiveness This chapter offers a description of the current treatment setting for opiate and cocaine addiction; approaches, patient demographics, and the effectiveness and cost-effectiveness of existing treatments are examined. The treatment system for opiate addiction and that for cocaine addiction are described separately because they offer two distinct markets for pharmaceutical development. For example, a new agonist medication for opiate addiction would most likely compete with the two currently approved pharmacotherapies methadone and levo-alpha-acetylmethadol (LAAM). Yet, a new medication for cocaine addiction would have little competition, if any, because there is no existing medication that consistently prevents relapse to cocaine addiction. TREATMENT SETTING Opiate Addiction Methadone maintenance with counseling is the treatment of choice for opiate addiction (McLellan et al., 19931. Treatment is provided in tightly regulated programs or clinics, which, until recently have been called "methadone clinics" because methadone has been the only pharmacotherapy approved for opiate addiction. In 1989, the federal treatment regulations were revised and the methadone-specific terms were generalized to say "narcotic treatment" or "narcotic drug" (Federal Register, 19891. Methadone clinics were designated (15
96 DEVELOPMENT OF MEDICATIONS "narcotic treatment programs" to encompass the diversity of available pharmaco- therapies. Throughout the United States, there are an estimated 650 methadone maintenance programs. They are almost universally located in outpatient facilities, and they must adhere to strict federal and state regulations concerning the use of a narcotic to treat narcotic addiction (Chapters 7 and 8~. Since 1987, the number of new clinics nationwide has grown by a modest 16.2 percent (IOM, 1995), despite policies designed to increase access to treatment. In New York, which has the largest opiate-dependent population in the country, only three new methadone clinics have been licensed in 20 years. A typical methadone maintenance program has four functional areas: a dispensing site, counseling offices, examining rooms, and an administrative area (Ball and Ross, 1991~. Patients usually receive a daily oral methadone dose and often have the privilege of a Sunday take-home dose. As the patients progress in treatment, they can be given additional take-home doses, a privilege that is revocable if the patient uses illegal drugs or does not comply with other program requirements. There is wide variation in patient dosing, and many patients receive insufficient doses of methadone (Ball and Ross, 1991; D'Aunno and Vaughn, 1992). Patients are required to undergo urinalysis to monitor abstinence Tom illegal drugs while they are in treatment. They also receive counseling at a frequency of usually two individual counseling sessions per month (Ball and Ross, 1991~. Patients participate in group counseling and also can receive vocational, rehabilitative, and acquired immune deficiency syndrome (AIDS) counseling. Most clinics are staffed by counselors, nurses, and social workers. Although all clinics are required by federal regulations to have a licensed physician serve as the designated medical director (21 CFR § 291.505), physician time devoted to direct patient care varies greatly depending on the program. Only 16 percent of methadone clinics have full-time physicians on staff (D'Aunno and Vaughn, 1992), and a study of six separate programs noted that physicians treat between 3 percent and 25 percent of patients each week (Ball and Ross, 19911. Physicians and other medical staff members such as nurse practitioners or physician assistants, are responsible for medical management, medications management, physical examinations, and medical education. Nurses are primarily responsible for dispensing medication (Ball and Ross, 1991~. This figure is an average of the number of units (574) reported to the National Drug and Alcohol Treatment Unit Survey (NDATUS) in 1992 and the number of dispensing
TREATMENT SErrING 97 Utilization of available spaces in methadone clinics is extremely high. In 1992, the nationwide utilization rate was 85.3 percent, according to the 1992 National Drug and Alcoholism Treatment Survey (NDATUS),2 although other estimates are even higher. The rate is calculated by dividing the actual number of patients by the capacity, or the number of treatment slots. The high rate has led to waiting times for treatment, especially in California and New York, but there are insufficient data on waiting times (IOM, 1995~. Some clinics do not keep waiting lists, and some potential patients are so discouraged by waiting lists that they fail to request a slot. A more thorough description of use rates arid waiting times is contained in a forthcoming Institute of Medicine report (IOM, 1995~. Most methadone clinics are owned by private, nonprofit organizations, which serve almost 60 percent of patients, according to the 1992 NDATUS. Nonprofit organizations and public agencies together serve more than 75 percent of patients. The private for-profit sector serves about 24 percent of patients, yet it is the fastest growing: from 1987 to 1992, there was a 92.5 percent increase in the number of patients served by privately owned, for-profit facilities. The not- for-profit sector witnessed a patient increase of 18.2 percent. Most of the growth in the for-profit sector has occurred in the southeastern United States, in Texas and California (M. Parrino, American Methadone Treatment Association, personal communication). Cocaine Addiction Most cocaine-dependent patients are treated in ambulatory settings (Figure 4.1), but the nature of their care is more diverse. Within ambulatory settings, there are two major modalities of cocaine addiction treatment: out-patient drug- free (ODE) and methadone maintenance. Even though the programs are geared toward opiate addiction, a large percentage of patients in methadone programs also are cocaine users, as described later. A smaller percentage of cocaine- dependent patients are treated in residential settings, in which the two major treatment modalities are therapeutic communities (TCs) and chemical dependency (CD) programs. 2NDATUS is the most comprehensive survey of all drug abuse and alcoholism treatment facilities throughout the United States. Treatment providers furnish prevalence, use, and financing data to their respective state agencies, which in turn forward the data to the Substance Abuse and Mental Health Services Administration (SAMHSA). Data from the 1992 NDATUS presented in this chapter are not yet published. These data were graciously offered to IOM by Daniel Melnick, Ph.D., acting director, Office of Applied Studies, SAMHSA.
98 DEVELOPMENT OF MEDICATIONS Hospital 1.5% Ambulator 85.0% ~ Long-Term. 10.5% Short-Term 3.0% tIGUKE 4.} Percentage of patients in treatment by sewing. the population includes patients in treatment for drug dependence and those in treatment for combined dependence on drugs and alcohol. These data are from the National Drug and Alcoholism Treatment Survey, September 30, 1991. *Residential. SOURCE: U.S. DHHS, 1993. For each of these four treatment modalities for cocaine-dependent patients, Table 4.1 characterizes the setting in which the treatment is administered, the services provided, and the percentage of patients dependent on cocaine prior to treatment. Outpatient drug-free programs are most common, serving the largest share of patients in treatment (Batten et al., 1993; U.S. DHHS, 19931. The programs provide counseling as the predominant form of treatment, but there is great variation in the array and intensity of counseling services, the quality and training of treatment staff, and the composition of patients. Although about 21 percent of patients in ODF programs are dependent primarily on cocaine or crack, the most commonly abused drugs are alcohol and marijuana (Batten et al., 19929. There also are opiate-dependent patients in treatment; the original goal of ODF programs was to provide a community-based alternative to methadone treatment. ODF programs initially served as "crisis centers" but have evolved into longer term treatment programs (Hubbard et al., 1989~. They have increasing allure to patients, insurers, and policy makers because the typical course of treatment is much less expensive than that offered by inpatient and residential programs. Patients are given individual or group psychotherapy or counseling usually once or twice a week, and a treatment episode lasts several months. The term "outpatient drug-free" is somewhat of a misnomer because in many of these programs physicians prescribe medications such as desipramine to treat cocaine craving and clonidine to treat narcotic withdrawal (Anglin and Hser, 1992; C. Wright, FDA, personal communication).
TREATMENT SETTING TABLE 4.1 Treatments for Cocaine and Opiate Addiction 99 Patients Using Cocaine or Opiates in last 30 Daysb Treatment Modality Setting Services CocaineC Opiates Outpatient drug-free Methadone maintenance Outpatient Outpatient Chemical Residential/ dependency hospital Therapeutic Residential community Counseling Prescription dogma 21% 10% Phannacotherapy 39% 83% Counseling Counseling Prescription digs 550/oc / 42%6 f go/Oc / 14%6f Counseling 55°/O ~9O/oC aNot all outpatient drug-free programs prescribe medication, but those that do commonly prescribe tricyclic anti-depressants, benzodiazepines, among others (C. Wright, FDA, personal communication, 1994~. bCategories are not mutually exclusive; patients are counted in any of 10 combined categories of drugs, depending on mentions of the drug in the discharge records. CIncludes crack cocaine. The first percentage refers to the residential setting and the second refers to the hospital inpatient setting. CFigure refers to residential setting rather than treatment modality because there is no separate breakdown for chemical dependency programs or therapeutic communities (in Table 30, Batten et al., 1992~. fFigure refers to hospital inpatient setting rather than modality because there is no separate listing for hospital-based chemical dependency programs (in Table 30, Batten etal., 1992~. SOURCES: IOM, 1990; Batten et al., 1992. Methadone maintenance programs, although geared toward opiate-dependent patients, have witnessed an increase in patients who are poly-drug users. About 39 percent of patients in methadone maintenance programs report having used cocaine prior to treatment (Batten et al., 1992~. While in methadone treatment, cocaine use varies widely. A recent review article (Condelli et al., 1991) cites several studies that have documented concomitant cocaine use in as few as 16 percent and as many as 75 percent of methadone patients. One study, conducted by the General Accounting Office (GAO, 1990) found cocaine use to occur in more than 20 percent of patients in more than one-third of the methadone programs under study. Some methadone programs do not provide any additional
100 DEVELOPMENT OF MEDICATIONS services for cocaine users; others have instituted behavioral interventions such as rewarding patients who cease cocaine use with additional methadone take-home doses (Condelli et al., 1991~. Therapeutic communities are highly structured long-term residential programs tailored primarily to the hard-core user. Over the 9 to 12 months of treatment, therapeutic communities emphasize complete abstinence from drug use And other changes in lifestyle. The philosophy is to create a productive, alternative environment for those whose addiction has led to criminal and anti- social behavior. The staff are mostly recovered drug-users. Most TCs are strongly opposed to pharmacotherapy of any kind. Only 5.6 percent of patients receive treatment in long-term TC programs (U.S. DHHS, 1993~. Chemical dependency programs are mostly short-term residential programs that were developed for alcoholics. They use the 12-step model of Alcoholics Anonymous to facilitate recovery. With the surge in cocaine use in the 1980s, more than one-half of the patients in chemical dependency programs were cocaine users (Rawson et al., 1991~. The treatment model developed for alcoholism was applied to cocaine dependence with little modification. The goal is complete abstinence accompanied by lifestyle change. Intensive counseling is often provided by psychologists, psychiatrists, and recovered drug users. Even though the emphasis of treatment is on counseling, prescription drugs such as anti-depressants and benzodiazepines are often used. In the 1 980s, CD programs were often found in hospitals, but the cost of a typical 28-day stay was so prohibitive that insurers began to restrict coverage for hospital-based CD programs. Consequently, most CD programs have been moved to residential settings (Rawson et al., 1991), and they are generally the treatment of choice for patients who have private insurance (IOM, 1990~. DEMOGRAPHIC AND FINANCIAL PROFILE The separation of opiate- and cocaine-dependent populations must be understood as somewhat artificial because poly-drug use has become the norm (McLellan et al., in press). Nevertheless, researchers and practitioners recognize that many persons who are dependent on drugs have a clearly defined preference for a particular drug, as defined by the duration and intensity of past use. This drug is often referred to as the primary drug of abuse. Therefore, whenever this chapter refers to an "opiate-dependent" or a "cocaine-dependent" patient, it should be understood that this assignation refers to the primary drug. It must be underscored that the demographic and financial data presented here concerns patients in specialty treatment programs, those programs dedicated to drug-abuse treatment in free-standing clinics or in a specialized wing of a
TREATMENT SETTING 101 hospital. Similar data are not available for patients who receive treatment in nonspecialty settings. Opiate-Dependent Patients There are an estimated 1 million regular users of illicit opiates and an estimated 500,000 opiate-addicted individuals in the United States (Kreek, 1992~. Only a fraction of opiate-dependent patients an estimated 117,000 patients received methadone maintenance treatment in 1993 (Harwood et al., 1994~. That point is relevant for the pharmaceutical industry, as they are interested in the two subsets of opiate addicts: those currently in treatment, and those who might come in for treatment if other pharmacologic modalities were available. The demographics of opiate-dependent patients in methadone maintenance programs are presented in Table 4.2. Much of these data are drawn from national or nationally representative data sets NDATUS, the Client Data System (CDS)3 (SAMHSA, 1994), and the Drug Services Research Survey4 (Batten et al., 1992; 1993~. Almost 50 percent of patients are located in New York and California (U.S. DHHS, 1993~. About 67 percent of methadone patients are male (SAMHSA, 1994~. Methadone patients are somewhat older than are cocaine-dependent patients in drug treatment. Almost 23 percent of methadone patients are ages 20-29, and another 75 percent are over age 30. By comparison, 44 percent of cocaine- dependent patients are ages 20-25, and 51.5 percent are over age 30 (SAMHSA, 1994~. Employment indicators reveal that almost half of methadone patients are not in the labor force, about 32 percent are unemployed, and only 24 percent are employed part or full time (SAMHSA, 1994~. There are no nationwide data on 3The Client Data System (CDS) is an annual and voluntary reporting system on admissions to specialty substance abuse treatment programs throughout the United States. Most of the programs receive some public funds. The 1992 CDS contains information for 40 states, the District of Columbia, and Puerto Rico, covering 89 percent of the U.S. population. 4The Drug Services Research Survey (DSRS) was conducted in two phases a nationally representative sample of drug treatment facilities (Phase I) and a survey of client discharge records (Phase II). The objective was to gather data on the characteristics of drug treatment facilities, clients in treatment, and financing. Phase I collected data from treatment facilities for the point prevalence date of March 30, 1990, and for their most recent 12-month reporting period. Phase II examined a sample of the records of 2,182 clients discharged from treatment facilities during the 12 months between September 1, 1989, and August 31, 1990.
102 DEVELOPMENT OF MEDICATIONS methadone patient income levels. Yet one large study of 22 publicly and privately funded programs found that opiate-dependent patients (N = 195) had an average income of $417 in the 30 days before treatment (McLellan et al., in press). Taken together, the employment and income data support the commonly held view that most methadone patients are indigent. TABLE 4.2 Demographics of Methadone and Cocaine-Dependent Patients in Treatment' Characteristics Methadone Cocaine-Dependent Patients Patients Patients in treatment, 1993 117,0002 C 300,000-400,0003 Admissions, 19924 112,016 385,699 Aged 2~24 years 7.6% 16.0% 25-29 years 15.2% 27.7% 30-34 years 22.5% 27.0% 35-44 years 41.6% 21.2% 45+ years 11.1% 3.3% Males 66.5% 66.6% Married 22%g 22-32%6 Employment status Not employed 31.6% 31.8% Employed full-time 18.2% 19.7% Employed part-time 5.6% 5.4% Not in labor force 44.6% 43.1% Average income 30 days prior to treatment $417a $6138 Annual NA $24,0007 Length of stay in days" 321 1098 Health insurances None 49.4% 53.9% Medicaid 16.5% 11.0% Private insurance 4.2% 5.1% Blue Cross/Blue Shield 3.2% 2.8% Medicare 1.5% 0.8% HMO 1.8% 1.7% Unknown 21.1% 22.4%
TREATMENT SETTING TABLE 4.2 Continued 103 Characteristics Methadone Cocaine-Dependent Patients Patients Primal source of payment at admissions ~ Private health insurance 5.2% 6.8% Medicaid 15.4% 11.7% Client fees (self-pay) 21.5% 20.1% Unknown 22.0% 20.3% 'The patient populations in this table are divided according to primal drug of abuse. Extrapolation from NDATUS 1991 point prevalence of 95,286 patients in treatment by Harwood and co-workers (1994~. 3Assumes 3~40 percent of the estimated I million patients in treatment in 1993 (Harwood et al., 1994) are primarily dependent on cocaine or crack. fin the CDS, health insurance information is collected irrespective of whether it covers the current treatment episode. Health insurance status is an optional data item reported by 21 states and jurisdictions, covering 42 percent ofthe U.S. population (SAMHSA, 1994~. 5This information refers to the treatment episode in which the data were collected. Primal source of payment is an optional data item reported by 17 states and jurisdictions, covering 19 percent of the U.S. population (SAMHSA, 1994~. 6Ranges were compiled from three studies with large, but not necessarily nationally representative, samples (McLellan et al., in press; Rawson et al., 1993; Means et al., 1989~. 7Average income from sample studied 198~1989, unadjusted for inflation (Rawson et al., 1993~. Figure refers to all patients in a nationally representative sample of drug and alcohol treatment programs, irrespective of primary drug of abuse. Breakdowns for cocaine- dependent patients are not available from the published report. The figure of 109 days averages hospital inpatients (23.9 days), residential patients (47.4 days), and ODE (177.9 days), among other modalities (Batten et al., 1992~. SOURCES: McLellan et al., in pressa; Butynski et al., 1994b; Harwood et al., 1994C; SAMHSA, 19944; Rawson et al., 1993C; U.S. DHHS, 1993f; Batten et al., 1992g; Means et al., 1989h. Very few patients have private health insurance, and even fewer use their insurance to pay for treatment. According to the 1992 Client Data System (CDS) 9.2 percent of patients have private insurance, but only 5.2 percent of patients list
104 DEVELOPMENT OF MEDICATIONS it as the expected source of payment at the time of admission to treatment.5 About 15.4 percent of patients list Medicaid as the expected source of payment. Many of the remaining patients about 21.5 percent plan to pay for their own treatment (SAMHSA, 1994~. It is surprising that so few patients have or use private health insurance to pay for treatment, given that almost one-quarter of patients are employed. Privately insured patients might be afraid to report or to take advantage of their coverage because they fear employer notification or their policies may be overly restrictive.6 The dearth of insured patients is underscored by financing data presented in Chapter 5. Those data show that private insurance accounts for 2.5 percent and 11.5 percent of methadone and cocaine treatment financing, respectively. Methadone maintenance treatment is considered long-term. The average length of stay-the time from admission to discharge is 320 days, yet owing to wide variability, the median length of stay is 4.5 months (Batten et al., 1992~. Some patients remain in treatment indefinitely; others eventually reduce their methadone doses to abstinence, thereby concluding treatment. Attesting to the chronic, relapsing nature of opiate addiction is the finding that almost 80 percent of methadone patients admitted to and discharged from treatment have had prior treatment episodes. Those patients average 3.4 previous treatment episodes, 1.4 of which occulted in the prior year (Batten et al., 1992~. Cocaine-Dependent Patients The primary source of nationwide data on the demographic characteristics of cocaine-dependent patients admitted to treatment is the Client Data System (CDS) sponsored by the Substance Abuse and Mental Health Services Adminis- tration (SAMHSA) (1994~. Other national or nationally representative data bases generally do not stratify the data by drug of abuse. Because CDS is based on admissions admissions are usually higher than the number of clients in treatment because clients are often readmitted to treatment in the same year-it does not contain estimates of the number of patients in treatment. Yet it can be reasonably estimated that the number of patients In treatment in 1993 was 300,000~00,000. That figure assumes 30~0 5Data items on health insurance coverage in general (regardless of whether it is used) and on the primary source of payment for a treatment admission are optional and reported by 21 and 17 states and jurisdictions, respectively, covering 42 percent and 19 percent of the U.S. population. 6Restrictions take the form of preexisting condition limitations and limits on the number of inpatient days, outpatient visits, or both (Chapter 51.
TREATMENT SEWING 105 percent of the estimated 1 million patients in treatment in 1993 (Harwood et al., 1994) used cocaine before entering treatment. That assumption is partly based on the Drug Services Research Survey (DSRS), which found that 31 percent of all patients in treatment report having used cocaine or crack in the 30 days before admission (Batten et al., 19921. DSRS was conducted in 1990, and since that time there is evidence that the percentage of cocaine-dependent patients in treatment is increasing. Butynski and co-workers (1994) report that admissions to cocaine addiction treatment programs escalated from 18.9 percent in 1987 to 36.1 percent in 1990 then reached 44.8 percent of all treatment admissions in 1992. The rise in cocaine admissions could reflect, among other factors, increased cocaine consumption by heavy users, especially of crack cocaine (Gfroerer and Brodsky, 1993~. Over the past decade, there has been a decline in the number of light users, yet no decline in the number of heavy users (Rydell and Everingham, 1994~. Cocaine-dependent patients also frequently use alcohol and marijuana (Washton, 1990; Rawson et al., 1993; McLellan et al., in press). The consump- tion of alcohol and the smoking of marijuana help to ameliorate the intense stimulant effect of high-dose cocaine (Washton, 1990~. In comparison with methadone patients, cocaine-dependent patients tend to be somewhat younger and have shorter lengths of stay in treatment (Table 4.21. Apart from these differences, the opiate- and cocaine-dependent patient populations are very similar (although it must be remembered that CDS data are biased in favor of publicly funded programs). Sex, marital status, employment, and health insurance indicators are quite similar. One of the only differences is that fewer cocaine-dependent patients are either insured by or use Medicaid. Income levels are not reported in national surveys partly because of the difficulty in obtaining accurate information from patients who might have illegal income. The income data presented in Table 4.2 are compiled from large, but not necessarily nationally representative, studies. In one of those studies, cocaine- dependent patients enrolled in 22 publicly and privately funded programs in the Philadelphia area reported earnings from the 30 days before admission that were 32 percent higher than were earnings for opiate-dependent patients (McLellan et al., in press). Annual income of patients in treatment has been reported in two studies, both of which pertain to cocaine. Rawson and co-workers (1993) found a mean legal annual income of $24,000 among a sample of 486 patients entering cocaine addiction treatment programs in Los Angeles between 1986 and 1989. That figure averages patient groups at two clinics, one of which was located in affluent Beverly Hills and the other in a low-income area in San Bernardino County. A smaller study of 81 outpatients in treatment in New York between 1985 and 1986 revealed that 53 percent reported incomes of less than $25,000, 16 percent reported incomes above $25,000; and 30 percent did not report income (Means et al., 1989~. Those studies collectively suggest that cocaine
106 DEVELOPMENT OF MEDICATIONS dependent patients could be financially better off than opiate-dependent patients, but it is unknown whether the data are nationally representative or reflective of current patients. The epidemic of cocaine use among the upper and middle classes in the mid-1980s appears to have abated, only to be replaced by an increase in dependence on the more affordable and more dangerous crack cocaine among lower income users (Rawson et al., 1991~. Of those factors, inadequate dosing and inadequate time in treatment have received much attention as reasons for treatment failure (IOM, 19901. D'Aunno and Vaughn (1992) found that 33 percent of treatment programs in a nationally random sample of 172 methadone treatment programs administered average doses of 41-50 milligrams, and 34 percent administered doses between 10~0 milli- grams amounts that are below the recommended dose of at least 60 milligrams (NIDA, 1989~. Low dosage, as mandated by some states, recommended by others, is countertherapeutic. When higher doses are administered, patients have longer average lengths of time in treatment, which is by itself an independent predictor of better treatment outcomes (IOM, 1990; Prendergast et al., in press). For example, in a randomized, double-blind, placebo-controlled study, patients who received the highest dose of methadone had better retention in treatment than did those who received lower doses. Those same patients also had the greatest reductions in opiate and cocaine use while in treatment (Strain et al., 1993~. TREATMENT EFFECTIVENESS AND COST-EFFECTIVENESS Methadone Maintenance Treatment Effectiveness There is strong consensus that methadone maintenance treatment is effective for the treatment of opiate addiction (IOM, 1990; OTA, 1990; Anglin and Hser, 1992; Prendergast et al., in press). The results of a large body of research reveal that treatment works; patients fare better during and long after treatment than before treatment. They also have better outcomes than do those who are untreated, those who are on waiting lists for treatment, and those who are simply detoxified with methadone. The best measure of treatment effectiveness is reduced opiate use. Other measures are reduced use of alcohol and other drugs, reduced criminal activity, reduced intravenous drug use, and reduced health care costs. When relapse to opiate use does occur after treatment, it should be interpreted as a reflection of the chronic and relapsing nature of addiction, the quality of treatment, or patient characteristics (Tims et al., 1991; McLellan et al., in press).
TREATMENT SETTING 107 An important study by McLellan and co-workers (1993) confirms the effectiveness of methadone maintenance by revealing the critical role of counseling and rehabilitative services offered along with pharmacotherapy. The study employs random assignment to treatment groups, thereby overcoming some of the problems plaguing earlier research, which used naturalistic settings and patient self-assignments (Tims et al., 1991~. After assigning patients to three different groups with varying levels of care, McLellan and co-workers found that patients given methadone and a comprehensive array of treatment services had significantly better treatment outcomes than did those who were given methadone and counseling, and than did those given methadone alone. Figure 4.2 illustrates the benefits of comprehensive treatment in reducing opiate usage over 16 weeks of treatment. After this intensive treatment regimen, patients sometimes require less counseling to succeed in treatment (T. McLellan, University of Pennsylvania, personal communication, 1994~. 120 a 0- - <~, 100 ~ 80 oh an ._ $ 40 ce 20 Q o O 1 00 94 60~ i ;' 28 . it. weeks 12 weeks16 weeks Length of Treabnent Methadone Alone Methadone With Counseling and Rehabilitative Services ~ Methadone with Counseling FIGURE 4.2 Electiveness of methadone with counseling and rehabilitative services. SOURCE: McLellan et al., 1993. Unfortunately, the real world of treatment stands in sharp contrast to the research setting. There is great variability in the effectiveness of treatment (Ball and Ross, 1991~. For instance, GAO (1990) found that at 10 of 24 treatment programs, a range of 21~7 percent of patients were using heroin after 6 months of treatment. The variability in outcomes can be attributed to many factors, including inadequate dosing, length of time in treatment, program policies, staff
108 DEVELOPMENT OF MEDICATIONS quality, and patient characteristics (e.g., severity of the problem, health and insurance status, and patient compliance with treatment). Cost-Effectiveness7 Current estimates used in Figure 4.3 place the average cost per methadone admission to a treatment program at $1,390 (Harwood et al., 1994~. Those costs are not dissimilar to those from a decade ago when a large study of methadone's cost-effectiveness was conducted.8 The Treatment Outcome Prospective Study (TOPS) followed 1 1,000 patients in 41 treatment programs nationwide (Harwood et al., 1988; Hubbard et al., 1989~. The investigators compared the cost of treatment with the benefits Mom reduced criminal activity during treatment arid one year after treatment. They found that the ratio of benefits-to-costs was 4 to 1, when they defined the benefits in terms of reduced costs to victims, reduced criminal justice costs, and reduced losses owing to theft. Those benefits were described collectively as the benefits to "law-abiding citizens" because they included benefits that were only realized by the victims. The benefit-to-cost ratio was not as robust, using a broader measure of overall societal benefits (Hubbard et al., 19891. That second measure included the societal benefit of enhanced legitimate earnings by the drug abuser following treatment. Since drug abusers' earnings were not found to increase after treatment, overall societal benefits were not as great as the benefits to-law abiding citizens.9 There is strong evidence 7In this chapter, the terms "cost-effectiveness" and "cost-benefit" are used synonymously. Technically, eost-effeetiveness is the relationship between program costs, which are measured in dollars, and program effects, which are measured in other units. Cost-benefit analysis is the relationship between program costs and the benefits, both measured in dollars (Apsler and Harding, 1991~. The National Institute on Drug Abuse (NIDA) is currently conducting the Drug Abuse Treatment Outcome Study, under contract with Research Triangle Institute. This is a multiyear, longitudinal study of 10,000 adult clients in 80 of the best treatment programs in 12 cities. In addition, SAMHSA is supporting the Services Research Outcomes Study on a cohort of clients after treatment for substance abuse. The analysis will focus on treatment outcome:' in relation to provider and staff characteristics and to the costs of treatment.. 9The benefits to '.law-abidir,g" citizens is a measure defined by the study authors to emphasize benefits which are experienced by the victims and their families, such as reduced losses from property or money stolen during a crime. By contrast, there is no net benefit to society the other benefit measure when theft takes place, because the value of the stolen goods is transferred from the law-abiding citizen to the criminal.
TREATA'IENT SE77ING 109 from research on alcohol dependence that treatment can significantly reduce overall medical costs (Holder and Those, 1992), but until recently, there has been only limited research on the medical offsets of treatment for drug dependence. 6,000 5,000 4,000 ,-g 3,000 2,000 1 ,000 o $1,390 $5.107 1 $762 MeU~dore Maint. Cocaine Out Cocaine Residential Treatment FIGURE 4.3 Average cost per admission for methadone (in 1993 dollars and cocaine treatment (in 1992 dollars~b. SOURCES: Harwood et al., 1994a; Rydell and Everingham, 1 994b. A new study of cost-effectiveness in the state of California was published in July 1994 (Gerstein et al., 1994~. The California Drug and Alcohol Treatment Assessment (CALDATA) analyzed the consequences of four treatment modalities, including methadone maintenance, on a random sample of 3,000 patients in treatment or discharged in fiscal year (FY) 1992. The sample was designed to represent almost 150,000 patients in treatment programs throughout the state. It was the first to compare the cost of treatment with the economic benefits not only in crime reduction and productivity, but also in health care use. The analysis used two separate benefit measures, similar to those in TOPS (i.e., the benefits to tax-paying citizens and the benefits to society but incorporated measures of health care use. Study subjects were interviewed an average of 15 '°CALDATA measured benefits in terms of avoiding costs to tax-paying citizens and avoiding costs to society. However, for clarity these terms are referred to here as benefits to tax-paying citizens and benefits to society.
110 DEVELOPMENT OF MEDICATIONS months after treatment and asked to recall the frequency of criminal, health, and productivity characteristics and behaviors before, during, and after treatment. By assigning monetary values to those characteristics and behaviors, researchers were able to calculate savings (or benefits) during and after treatment by comparison with the year before treatment. The overall benefit-to-cost ratio to taxpayers from all treatment modalities was 7.1 to 1. That was higher than the benefit-to-cost ratio to society (2.2 to 1~. For methadone treatment, the analysis was stratified by methadone patients discharged from treatment and those continuing in treatment. Methadone patients continuing in treatment are long-term patients who were still in treatment at the time CALDATA was conducted. The percentage of discharged patients who used heroin declined by 46.5 percent in comparison to before treatment. Health care expenditures for methadone discharges measured in terms of emergency room use and outpatient and inpatient health and mental health care-declined by 20.6 percent. Their legitimate earnings after treatment decreased by 33 percent, a finding that suggested to the authors that the short period of treatment was unsuccessful at helping them become gainfully employed. Health care expendi- tures for methadone patients who continued in treatment declined by 12.6 percent in comparison to before treatment. For this same group, legitimate earnings increased during treatment by about 10 percent. When all the benefit and cost measures were taken into account for each category of methadone patient, the ratio was favorable. The benefit-to-cost ratio was 12.6 to 1 for discharged methadone patients and 4.8 to l for methadone patients continuing in treatment, when the benefits were measured for taxpayers. The benefit-to-cost ratio was -3 to l and 4.7 to 1, respectively, when the more conservative measure of benefits to society was analyzed. One final point bears emphasis. It is often noted that treatment is far less costly than alternatives such as untreated addiction, incarceration and parole. Supporting this commonly held view, Figure 4.4 compares the annual cost of treatment with these alternatives. To lend empirical support, Deschenes and co- workers (1991 ) studied the careers of about 300 heroin-dependent persons before and during treatment. The annual cost per person for arrests, incarceration, and parole dropped by about half (from about $8,000-$9,000 to about $4,000) when active addiction ceased and treatment began. Cocaine Addiction Treatment Effectiveness A variety of outpatient and residential treatments are available for cocaine addiction, most of which offer counseling in the form of group and individual
1 TREATMENT SETTING 111 therapy. Although there is some prescribing of medications to help achieve abstinence and prevent relapse, none of the available medications are effective in consistently reducing return to cocaine use (Chapter 2~. An accumulating body of research points to some effectiveness for specific types of cocaine addiction t~eaknent and to better outcomes for patients who remain in treatment longer (IOM, 1990; Prendergast et al., in press). However, there is no consensus about the most effective treatment modality for cocaine addiction (Leukefeld and Tims, 1993; Carroll et al., 1994~. The problem is that much of the research has focused on individual treatment modalities rather than on the comparative efficacy of different modalities. The study designs typically compare pre- to post-treatment gains in abstinence. When studies are conducted to make comparisons across ~ . ~ ~ · ~ . ~ 1 ~ A ~ ^L _C ^C ~ modalities, patients are randomly assigned IO one mouallly. ~lmougn Into is ills best method for accurate comparison, it often results in the majority of patients dropping out of the assigned treatment. Untreated Addiction Incarceration Probabm Cocaine Residential Methadone Maint. Cocaine Outpatient ~S2.72~ bee . ~ . I 0 10,000 20,000 30,000 40,000 50,000 Costs Per Person Per Year FIGURE 4.4 Treatment is less expensive than alternatives. NOTE: al991 dollars; bl992 dollars; C1993 dollars; 61992 dollars, inflation adjusted from 1983 data; CThe average cost per admission is much lower than this figure because most patients are in treatment less than 1 year. SOURCES: McLellan et al., 1994; Lewin-VHI, unpublished estimates; Rydell and Everingham, 1994; SAMHSA, 1994. There is growing awareness that no one treatment will work for everyone who is dependent on cocaine, and the choice of treatment could be dictated by the severity of addiction. In general, addiction treatment professionals support initial evaluation and case management to ensure that patients with more severe conditions are treated in settings with the highest intensity of services (such as
112 DEVELOPMENT OF MEDICATIONS residential settings) and that those with less severe addictions are treated in outpatient settings (ASAM, 1990; CASA, 1993~. TOPS is the largest and most frequently cited study of cocaine addiction treatment effectiveness (Hubbard et al., 1989~. For patients who remained in treatment 3 months or longer, somewhat less than half were abstinent 1 year after treatment. Among residential patients all of whom were in TCs- the prevalence of regular cocaine use declined from 28 percent before treatment to 16 percent one year after; among outpatient drug-free patients, the prevalence declined from 13 percent to 8 percent; and among outpatient methadone patients, the prevalence declined from 26 percent to 17 percent. The authors guard against strict comparisons across modalities because of patient self-selection to treatment and because of patient and program heterogeneity. TOPS did not examine the effectiveness of chemical dependency programs. Prendergast and colleagues (in press) observe that there are no well-designed studies of CD programs, but there are some limited studies showing treatment effectiveness. A study of 300 cocaine dependent males entering the West Los Angeles Veterans Administration Medical Center for inpatient, outpatient, or self-help programs found abstinence at the 12-month follow-up to be greatest among patients whose choice of treatment consisted of an initial 21-day inpatient period, an outpatient follow-up regimen, and continued involvement in self-help groups (Khalsa and Anglin, 1991~. A newer study of 649 drug-dependent patients admitted to 22 public and private programs both inpatient and outpatient in the Philadelphia area has found that, of the 212 cocaine-dependent patients entering treatment, 51 percent were abstinent from all illicit drugs at the follow- up interview 6 months after entering treatment (McLellan et al., 1994; in press). The study subjects included all patients who completed at least 5 inpatient days or at least two consecutive outpatient treatment sessions. Improvements also were found in measures of psychiatric, employment, and family status in addition to measures of improved public health and safety. For all study subjects, including cocaine, opiate, and alcohol patients, the degree of drug use at the 6-month follow-up was predicted by the greater severity of the drug abuse problem at the time of admission. The type of treatment-the number of psychosocial services such as psychotherapy, family therapy, and employment counseling-was not related to post-treatment drug use, but it was related to psychosocial adjustment after treatment. When stratifying that data and some additional data by whether the program was funded privately or publicly, it was found that private patients, all of whom were insured, were far healthier and had more resources as they entered treatment, received more services in treatment, and experienced 20~0 percent more improvement than did patients in publicly funded programs (Weisner and McLellan, 1994~. Never studies of cocaine addiction treatment effectiveness also have focused on particular types of structured outpatient programs. Encouraging findings from
TREATMENT SETTING 113 intensive outpatient programs have been reported by Washton and co-workers (Washton, 1990; Washton and Stone-Washton, 1993~. Using a neurobehavioral model, Rawson and co-workers (1993) reported that 40~4 percent of patients who completed 6 months of treatment attained abstinence during an open trial, a finding they hope to replicate in a randomized trial that is under way. Another treatment that deserves attention has been pioneered by Higgins and co-workers. Their outpatient regimen is a behavioral approach using contingency management procedures (Higgins et al., 1991; 1993~. That technique adapts the principles of operant conditioning to the treatment of cocaine abuse. Patients who remain abstinent during treatment accumulate vouchers of increasing value the longer they remain abstinent. The vouchers are worth up to about $1,000 over 12 weeks of treatment and can be used to purchase items selected by the patient and purchased by the counselor. The most recent study using random assignment to treatment groups found this behavioral approach superior to counseling in patient retention and abstinence (Higgins et al., 1993~. Cost-Effectiveness The average cost of an outpatient admission for cocaine addiction treatment, presented in Figure 4.3, is estimated at $762; the average cost of a residential admission is estimated at $5,107 (Rydell and Everingham, 1994~. Several major studies of cost-effectiveness have been undertaken. TOPS studied the cost of treatment in comparison to the benefits in crime reduction, as discussed earlier. The ratio of benefits to costs for each of the three treatment modalities studied (outpatient methadone, residential, outpatient drug-free) ranged from about 4 to 1 to about I to 1, depending on the modality and the benefit measure used. Even though this analysis focused on all of the patients in a given treatment modality, rather than on cocaine-addicted patients per se, the findings are relevant because cocaine use was found to varying degrees among patients in all three treatment modalities and was shown to decline from pretreatment levels. A new study from California (CALDATA), cited earlier, also analyzed the cost-benefits of residential and outpatient drug-free treatment modalities (Gerstein et al., 1994~. Cocaine was the primary drug of abuse in 29 percent of residential and 32 percent of outpatient drug-free (ODE) patients. The percentage of patients using cocaine in all treatment modalities declined by about 46 percent after treatment, pointing to treatment effectiveness. Favorable benefit-to-cost ratios were found, yet they varied according to treatment modality and the method used to assess benefits. For tax-paying citizens, the ratio of benefits-to-costs of treatment was 4.8 to 1 for residential patients and 11 to 1 for ODE patients. In terms of benefits to society, the ratio was 2.4 to 1 and 2.9 to 1, respectively.
114 DEVELOPMENT OF MEDICATIONS There is a recent, two-volume RAND study demonstrating the relative cost- effectiveness of treatment (Everingham and Rydell, 1994; Rydell and Ever- ingham, 1994~. Treatment was found to surpass all other societal control strategies in terms of relative cost-effectiveness. The study compared treatment (a demand control strategy) and three supply control strategies: source country control, interdiction, and domestic enforcement (cocaine seizures, arrests, and imprisonment of drug dealers). It calculated the cost required for each control strategy to achieve a common measure of effectiveness-a reduction in cocaine consumption- by 1 percent of current annual consumption. To meet this objective, researchers found that the additional cost of treatment would be $34 million, an amount 7.3 times less than that needed for the next most effective strategy, domestic enforcement, and 23 times less expensive than source control (Figure 4.5~. The researchers conclude, "Our findings suggest a way to make cocaine control policy more cost-effective: cut back on supply control programs and expand treatment of heavy users," (Rydell and Everingham, 1994~. coo 600 - E 400 200 o in_ Source Control Interdictlon Domestic Enforcement Treatment Cocaln+Control Programs FIGURE 4.5 Additional cost of reducing cocaine consumption by 1% win alternative cocaine-control programs. Treatment is the most cost-e~ective approach to reducing cocaine consumption. It is 7.3 times less costly than Me least expensive alternative, domestic enforcement, and 23 times less costly than source control. SOURCE: Rydell and Ever~ngham, 1 994. In the years ahead, even in the absence of a new medication, cocaine addiction treatment is likely to become even more cost-effective. Managed care, case management, and other medical cost containment approaches, which are
TREATMENT SE77ING 115 discussed in Chapter 5, are being used to shift patients from the inpatient to the outpatient setting. For example, Alterman and co-workers (1994) have found intensive day treatment to be as effective as and less expensive than inpatient treatment for cocaine addiction. Reductions in average treatment costs not only enhance the absolute cost-effectiveness of treatment, but they also increase the cost-effectiveness of treatment relative to other control strategies. Were a new and effective medication for cocaine addiction treatment to become available, treatment costs" could be reduced even further, through reduced counseling costs. That already has been demonstrated in the mental health field with the introduction of lithium for manic depression and clozapine for schizophrenia (Wyatt and de Saint Ghislain, in press). For example, savings of $1 billion per year (in 1991 dollars) in direct inpatient and outpatient costs have been realized since the marketing of lithium in 1970. A new cocaine medication does hold the opportunity to reduce some, but not all' of the counseling costs, as some degree of counseling, along with pharmacotherapy, as essential ingredients of cocaine addiction treatment will continue to be necessary, as research on methadone maintenance suggests (McLellan et al., 19931. CONCLUSIONS AND RECOMMENDATION Effective pharmacotherapies are currently marketed for opiate addiction, but not for cocaine addiction. Current treatment strategies for cocaine addiction depend mostly on a variety of counseling approaches undertaken in residential or outpatient settings. The opiate- and cocaine-dependent patient populations are similar, except with respect to age and length of stay in treatment. Cocaine- dependent patients tend to be younger and have shorter term treatment episodes. Unemployment and a lack of private health insurance are common among the opiate- and cocaine-dependent patient populations. About 10 percent have private insurance; an even smaller fraction appear to use their coverage to pay for an episode of treatment. Cocaine-dependent patients seem to have greater income than do opiate-dependent patients, but the evidence is not conclusive. Cocaine-dependent patients are perceived to have incomes higher than those of methadone patients, but this perception could be outdated because cocaine use, since the mid-1980s, appears to have declined among the middle and upper classes. Lack of insurance and insufficient patient resources to pay for treatment are frequently cited by the pharmaceutical industry as deterrents to pharmaceuti- cal investment. lathe current average cost per cocaine admission of $1,740. This figure is a weighted average of outpatient and residential treatment (Rydell and Everingham, 1994~.
116 DEVELOPMENT OF MEDICATIONS There is resounding evidence of treatment effectiveness for methadone maintenance. Treatment is effective in reducing opiate use, criminal activity, and intravenous drug use. The evidence of treatment effectiveness is not as strong for cocaine, yet there is an accumulating body of research pointing to the effec- tiveness of psychosocial treatment modalities. As yet, there is not a phannaco- logic agent for the treatment of cocaine addiction or a medication to reduce · . cocaine craving. Treatments for opiate and cocaine addiction are cost-effective. When the cost of opiates d cocaine-addiction treatment is compared to the benefits in reduced crime, the result is unambiguous: every dollar invested in treatment yields two and up to four dollars, and sometimes more, in societal benefits. Treatment also averts other health care costs. In short, current treatments for opiate and cocaine addiction, although variable in nature and cost, are effective and cost-effective. Clearly the federal government should make every effort to expand the treatment capabilities of the states. New medications, especially for cocaine addiction, do hold the potential to reduce some of the need for counseling, which forms the largest share of treatment charges. With lower overall treatment costs, treatment can prove to become even more cost-effective. Given the data presented on the effectiveness and cost-effectiveness of both opiate- and cocaine-addiction treatment, and in light of the evidence that treatment is far more cost-effective than are other control strategies, such as domestic enforcement, interdiction, and source country control, the federal government should make treatment a major component of its drug control strategies. The committee strongly recommends expanding the treatment capabilities of the states for opiate- and cocaine-dependent individu als to ensure that all those seeking treatment obtain it without delay. The recommendation may be implemented by: . Providing additional money to increase treatment in states where there are waiting lists. programs. Shifting money from supply control programs to treatment REFERENCES Alterman AI, O'Brien CP, McLellan AT, August DS, Snider EC, Droba M, CoInish JW, Hall CP, Raphaelson AH, Schrade FX. 1994. Effectiveness and costs of inpatient versus day hospital cocaine rehabilitation. Journal of Nervous and Mental Disorders 182:157-163.
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