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16
SUPPORTING THE SCIENTIFIC INFRASTRUCTURE
FOR TREATMENT RESEARCH
Steady progress has been made over the last decade in increasing the alcohol research
budget. In 1980, NIAAA's research support was $22.2 million, which included 167 research
projects. By fiscal year 1989, the institute's total research funding had grown to $107.1
million with 485 grants supported. Linked to this growth has been a significant
improvement in the knowledge base dealing with the biomedical and psychosocial aspects
of alcohol problems (IOM, 1987~. NIAAA supports programs of intramural and extramural
research that span basic, clinical, and epidemiological studies. Unfortunately, not until
1988, when NIAAA created its new Division of Clinical and Prevention Research, was
treatment research given a prominent place in the research portfolio. This previous lack
of support is reflected in the relatively small portions of the intramural (14 percent) and
extramural (12 percent) research budgets that are devoted to treatment-related research.
Until now NIAAA has relied on two mechanisms to fund treatment research: the
investigator-initiated (R01) grant and the research center. NIAAA funds a treatment
research center at the University of Connecticut Health Center in Farmington. The
Veterans Administration (VA) also funds a clinical research center at the San Diego VA
Hospital and has provided some support for treatment trials through its Merit Review
Program and through two multicenter collaborative studies. The NIAAA and VA research
support mechanisms have together led to improvements in methodology and theory and to
a slowly expanding pool of researchers and facilities.
However, one recent development that provokes serious concern is the cutback in the fiscal
year 1989 budget for VA health care programs. This cutback has already resulted in the
closing of alcohol treatment programs that were linked to important NIAAA- and
VA-funded research. Moreover, the new impediments that have been raised to the
admission to VA hospitals of non-se~vice-connected or indigent veterans will have a
disastrous effect on a number of major clinical and basic alcohol research programs.
Recently, the ADAMHA Office of Substance Abuse Prevention (OSAP) initiated support
through large-scale grants for a high-risk-youth demonstration project and community-based
programs, but these funding mechanisms have not provided adequate support for systematic
evaluation. For the federal government to begin to exploit the opportunities in treatment
research described in this report, it must address the need within the alcohol field to
develop a scientific infrastructure appropriate to the task. It is a challenge whose
dimensions have been previously charted by treatment and prevention research efforts at
the National Institutes of Health (NIH)--particularly the National Cancer Institute; the
National Heart, Lung, and Blood Institute; and the National Institute on Allergy and
Infectious Diseases in its program of AIDS research. Maintaining support for agencies and
programs that provide this infrastructure is essential.
Recent reviews of treatment efficacy (Saxe et al., 1983; Lettieri, Sayers, and Nelson, 1984;
Tims and Ludford, 1984; Miller and Hester, 1986) identified approximately 200 controlled
studies. Few of these studies, however, employed advanced clinical assessment
rr.ethodologies (e.g., assessments of comorbid psychopathology or severity of dependence).
Similarly, although 150 random assignment trials have been conducted, few have been
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devoted to comparisons of treatment modalities or settings in relation to outcome. Studies
of treatment efficacy are needed to define the dimensions of treatment outcome in relation
to the expected effects of treatment. Research should be designed and funded in such a
way that treatment effects can be examined not only at the termination of treatment but
(at least) one year beyond in order to investigate the potential enduring benefits of certain
treatment modalities and settings.
Although clinical trials were introduced as a method of scientific investigation before 1945
and have been used extensively in psychiatry and medicine since then, it is only recently
that large-scale clinical trials have been conducted in alcoholism treatment research (Fuller
et al., 1986~. The relative dearth of controlled trials and treatment matching research (see,
for example, Skinner, 1981) is in part a result of the lack of funding in this area and the
formidable practical and methodological challenges to researchers.
In the early development of new treatment modalities (e.g., a new pharmacotherapy for the
treatment of alcohol withdrawal), the investigator-initiated grant application (Rot) can be
utilized effectively to compare the new modality with established treatment practice.
Random assignment to treatment is highly desirable in this type of study. The
investigator-initiated grant may also be the mechanism of choice for studies of well-specified
treatment populations (e.g., minorities, women, military personnel, specific age cohorts) in
which the investigator has special access to the particular patient or client group. One
major disadvantage of the R01 application for these types of studies has been the
traditional limited funding period associated with this grant. Three years of funding may
not be adequate to initiate a study, collect a cohort of clients/patients who meet the
research criteria, and conduct adequate follow-up of a sufficient number of subjects at least
12 months after the treatment intervention. Treatment research grant announcements
should strongly encourage four- and five-year awards, with the requirement that the
proposal include adequate follow-up of a sufficient number of subjects for at least one year
after the treatment intervention.
Treatment research methods are often shaped by the requirements of the treatment
program, a factor that may limit the rigor of the research design. These studies are of
necessity scientifically less exact and more complex and difficult than other projects
reviewed by the existing grant review committees. There is a need to increase the number
of qualified treatment researchers through increased support for postdoctoral training in
relevant specialities (e.g., psychiatry, psychology, internal medicine, family medicine,
epidemiology, sociology, health care economics). The Scientist Development Award for
Clinicians appears to be an excellent vehicle for the career development of young
investigators interested in treatment (and prevention) research, but the present maximum
stipend of $45,000 per year is not adequate salary support for young physicians.
Center grants offer another vehicle for studying treatment research. For example, the
National Institute on Drug Abuse (NIDA) recently established three treatment research
centers with the stated goal of "systematically testting] existing and new treatment strategies
in well-controlled designs." Because of the need to develop large subject samples, NIDA
urged applicants to "consider the advantages of coordination between related studies, and
between Centers doing similar work." NIDA emphasized its interest in developing
treatment process as well as outcome data; it also urged the funded centers to develop
research training opportunities. In some respects, the new NIDA program is modeled after
NIAAA's highly successful, but more broadly based, alcohol research centers program.
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Only one of 12 NIAAA centers conducts alcohol treatment research. The latter program
includes studies at three sites: a VA hospital, a treatment program within a university
hospital, and a large outpatient program within a mental health center at a neighboring
university. Affiliations with several other institutions in the area have been essential to this
center in its efforts to maintain an adequate and diverse patient base for its treatment
research programs. (A postdoctoral research training program is also part of the core
activities of that center.) The committee suggests that NIAAA consider funding one or
more additional centers devoted to treatment research in collaboration with another federal
agency (e.g., the VA or the Department of Defense) or in conjunction with one of the
state-funded alcohol research centers.
A significant proportion of the alcohol treatment in this county takes place in freestanding
inpatient units that are generally not affiliated with major academic and research centers.
The rapid growth in the number of inpatient beds in proprietary and nonprofit facilities
over the past 15 years (Yahr, 1988) has stimulated a strong interest in research on
treatment settings and the matching of patient subtypes to specific treatments. This interest
has been expressed in many quarters: the Congress, the executive branch of the federal
government, the insurance industry, and the treatment community. Since the introduction
of the block grant program, NIAAA has lost its ability to evaluate community-based
treatment programs as it did in the 1970s through contracts with the Rand Corporation
(Armor, Polich, and Stambul, 1978; Polich, Armor, and Braiker, 1981~. The Rand studies
were generally limited by the sparseness of patient assessments, but the large number of
subjects who were studied across a wide variety of treatment settings provided important
information on differential routes to recovery among patients/clients who differed in the
severity of their alcohol dependence.
The committee commends the recent policy decision to set aside 5 to 15 percent of funds
within block grants to evaluate alcohol and drug abuse treatment programs and to
determine the quality and appropriateness of various forms of treatment (including the
effect of living in the types of housing provided in these programs). The evaluations are
to be funded through grants, contracts, or cooperative agreements provided to public and
nonprofit private entities. This policy could well encourage linkages among
university-affiliated researchers, state agencies, and not-for-profit treatment facilities.
A potentially important initiative was launched recently by a programmatic decision by the
leadership at NIAAA and NIDA to utilize the funds appropriated through Section 1923 of
the Public Health Service Act (an amendment added by the Anti-Drug Abuse Act of 1986)
to fund grants for up to five years to evaluate alcohol and cocaine treatments.
Unfortunately, the conditions of the appropriation mandated annual awards, with
continuation contingent on the availability of funds "and progress achieved." New grant
money in the amount of $2.3 million was made available for this purpose in fiscal year
1988. This program could be limited in achieving its stated goals because of uncertainties
regarding long-term funding and a failure to address the need to develop treatment research
networks of adequate size and diversity. This uncertainty about long-term support could
have a negative impact on the scientific dimensions of these evaluations and will also make
it more difficult to attract competent investigators to this important research area.
To systematically examine questions that relate to treatment setting and treatment matching,
it is essential to develop an adequate number of treatment facilities willing to participate
in controlled treatment trials. In this context, specific funds must be set aside for thorough
patient assessments at intake and at the follow-up point. These assessments must be
conducted with a high degree of reliability within and between sites. The optimal
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mechanisms for this type of study would appear to be the Cooperative agreements within
the Public Health Service and the "collaborative study within the VA As an example of
the latter, the conduct of the VA collaborative study on disulfiram (Fuller et al., 1986) has
been especially instructive. This study involved nine sites and 14 investigators. Out of an
initial pool of 6,629, researchers recruited 605 subjects. The small pool of eligible subjects
for this study highlights the formidable logistical problems involved in well-controlled
treatment research. The results also highlight the importance of rigorous experimental
design in these studies (Fuller et al., 1986~.
Table 16-1 compares regular research grants with cooperative agreements. Under a
cooperative agreement, institute staff work with the scientific community in a cooperative
venture. Institute staff and consultants assist colleagues in the scientific community in the
design of the study, project coordination, and the dissemination of research results. As a
mechanism for ensuring close cooperation between treatment facilities and investigators, and
as a means of securing large treatment samples from multiple sites, the cooperative
agreement is preferable to investigator-initiated grants.
Experience at NIH suggests that the cooperative agreement is an especially useful
instrument for the rapid transfer of knowledge from research to clinical practice. Examples
of cooperative agreements include the new network of AIDS clinical studies being funded
by the National Institute on Allergy and Infectious Disease and the Clinical Trials
Cooperative Groups supported by the National Cancer Institute (NCI). In the NCI
program, each project typically includes physicians from multiple medical centers who
cooperatively design and conduct clinical trials to evaluate treatment of various types and
stages of cancer. The data are collected and analyzed in a coordinating center. Most of
the participants are located at major medical centers in urban areas. The program was
further extended in 1976 to include the participation of physicians at community hospitals
and in private practice.
Similarly, the National Heart, Lung, and Blood Institute has funded placebo-controlled trials
in a multicenter program for the treatment of cardiac arrhythmia. Cooperative agreements
have also been utilized to test new diagnostic instruments. The National Institute of
Mental Health (NIMH), an ADAMHA institute, has used the cooperative agreement
mechanism to fund a multicenter collaborative study of depression to determine whether
different aspects of the disorder respond to different treatments (pharmacotherapy versus
psychotherapy). NIAAA is initiating cooperative agreements in fiscal year 1989, including
a multisite trial of alcoholism treatment that involves patient-treatment matching.
The use of the cooperative agreement to fund large-scale alcohol treatment research should
be encouraged. Similar to the VA collaborative study of disulfiram (Fuller et al., 1986),
the data from such treatment studies will benefit both the research and the clinical
communities. NIAAA staff could play a critical role in bringing together a network of
investigators and a variety of treatment facilities from the public and private sectors. In
this context, the requirements both of research design and of clinical practice can be
considered. NIAAA, the VA, the Health Care Financing Administration, and the
Department of Defense should also consider developing cost-sharing arrangements with
interested states, universities, service providers, and third-party payers.
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Table 1~1. Distinguishing Between Grants and Cooperative Agreements
Element Grant Cooperative Agreement
Intent Support or stimulation to Support or stimulation to accomplish a
accomplish a public purpose public purpose
Scope of work Any program activity Any program activity eligible under
eligible under NIH/ADAMHA legislation
NIHJADAMHA legislation
Initiation Applicant initiated; may be Awarding a component initiated through an
in response to an RFA or RFA or PA
PA
NIH/ADAMHA role Normal programmatic and Normal stewardship responsibilities plus
administrative stewardship substantial programmatic involvement
responsibilities; no during performance of award
substantial programmatic
involvement
Examples of staff Providing technical Participating in the design of activities
participation assistance at the recipient's
request
Close monitoring of an Advising in the selection of contractors,
external organization trainees, staff, etc.
- Ensuring compliance with Coordinating or participating in the
policy requirements and collection and/or analysis of data
- terms of award
Evaluating performance Advising in training and selection of project
through progress reports staff
and site visits
Reviewing and approving each stage of a
clinical trial
Advising on management and technical
performance
Participation in the preparation of
publications
Participation in all responsibilities required
by grants
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It should be recognized that multisite clinical trials are difficult to implement. Problems-
in this type of research include control over the therapies being delivered, quality control
over the selection and training of therapists, and developing an effective means of
monitoring day-to-day implementation of the research and clinical protocols. Cooperative
studies are best carried out after smaller, single-site studies have been conducted; such
smaller-scale research allows for careful specification and testing of procedures.
Cooperative efforts are easiest to implement in drug and assessment studies; they are most
feasible when the treatments under investigation are well specified, time limited, and
relatively easily taught.
Finally, in any consideration of scientific infrastructure, the federal government needs to
consider the personnel requirements that are essential to the conduct of treatment research.
In 1986, NIAAA supported four postdoctoral and two career development stipends that
could be classified as treatment research. In conjunction with the centers program and the
proposed cooperative agreements, NIAAA should target funding for additional scientists in
treatment research careers including epidemiologists, social and behavioral psychologists,
physicians (psychiatrists, internists. family nhv~im~n~N health C'~-C ~-c-~h~rc OVA
biostatisticians.
· __7 ~J I__ ~All ~-__ v_^ ~ ^__, ~ _ ~1-
Within the institute, new initiatives in the area of treatment research should be
complemented by the active use of outside consultants, planning panels, and other
mechanisms, such as the proposed Clinical Staff Program for Prevention and Treatment
Research. This program is designed to provide greater interaction among the intramural
research program, the extramural research program, and clinicians/researchers in the field.
This mechanism should also be used to attract visiting scientists to the institute for one-
or two-year periods.
Over the years NIAAA has developed a number of programs and activities that are capable
of stimulating research, facilitating technology transfer, and providing expert advice to the
field. These include not only research grants, training grants, the Alcohol Research Centers
program, and cooperative agreements but also planning panels, expert committee meetings,
research conferences, technical reviews, bilateral international agreements, interagency
agreements, contracts, and the intramural research program. NIAAA is also using a
developmental grant mechanism (R21) that offers up to two years of support ($40,000 in
direct costs per year) to assist institutions in building their capacity to do alcoholism
treatment research; conducting pilot studies that lead to expansion, enhancement, or
modification of existing treatment research programs; and planning and conducting pilot
research that can lead to the development of clinical trials. Projects aimed at the treatment
of alcoholism in special groups such as women, minorities, and defined age groups (e.g.,
adolescents and the elderly) have been encouraged under this mechanism.
There appears to be sufficient flexibility in NIAAA's operational mechanisms to permit the
implementation of the treatment research opportunities outlined in Part II of this report.
As new funding and funding mechanisms are brought into play, NIAAA should evaluate
the experience of other agencies that have been involved in clinical trials and large-scale
collaborative studies. For instance, NIDA has devoted a substantial proportion of its
research budget to treatment grants and has supported a longitudinal evaluation of drug
treatment programs (called the Treatment Outcome Perspective Study) since 1978. NIMH
has sponsored the NIMH Treatment of Depression Collaborative Research Program
through cooperative agreements with seven participating sites. The VA supports
investigator-initiated treatment grants through its Merit Review System and has sponsored
the VA collaborative study of disulfiram.
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International research may also offer some guidance. The alcohol research program of the
World Health Organization (WHO) has initiated international collaborative projects in the
areas of screening, early intervention, community responses to alcohol problems, and the
comparison of alcoholism treatment systems. These projects are typically funded through
cooperative agreements among collaborating research centers and health ministries. One
WHO program that has been beneficial to treatment research in the United States is the
WHO/ADAMHA program on nomenclature and classification of mental disorders and
alcohol- or drug-related problems. This program has facilitated the standardization of
nomenclature and diagnostic procedures with respect to alcohol-use disorders. It has also
led to the development of new diagnostic instruments that promise to assist treatment
planning and epidemiological research.
These programs not only serve as models for achieving some of NL\AA's goals for
treatment research, they also indicate that there may be large areas of common interest
among the various national and international agencies engaged in treatment research.
These indications take on added vitality in light of the growing participation of state and
private agencies in alcohol treatment research and program evaluation. A number of state
agencies now engage in treatment evaluation through their own information systems or in
cooperation with state-supported research centers. In addition, several private hospital
groups have established treatment evaluation components. What is needed is for NIAAA
to coordinate activities, divide responsibilities, and share data among the agencies and
organizations involved in similar pursuits. Given the recognized leadership position that
NIAAA has achieved in the field of treatment, the institute is in a unique position to form
a network of mutually beneficial partnerships among various agencies and organizations
that are involved in similar activities. By coordinating activities among such interest groups
as research centers, pharmaceutical companies, hospital chains, insurance companies, single
state agencies, and federal agencies, NIAAA may be able to guide the field toward a more
coherent course of action.
The committee makes the following recommendations for funding treatment research:
· The present research program of investigator-initiated grants should be enhanced to
encourage the funding of treatment research for periods up to five years. This expansion
will allow for start-up work and at least one year of posttreatment evaluation.
· There is a need to increase the pool of treatment research investigators. This goal
can be achieved by a variety of mechanisms including support of M.D./Ph.D. programs in
medical schools targeted toward clinical investigators in alcoholism. The newly initiated
Scientist Development Award for Clinicians should help to create a pool of young
investigators interested in treatment research.
· NIAAA should play a leadership role in bringing interested groups together to
support treatment research in the alcohol field. The National Heart, Lung, and Blood
Institute is interested in the effects of abstinence or reduced drinking on hypertension
secondary to excessive alcohol use. NIDA is interested in the treatment of polysubstance
abuse including cocaine, opiates, and alcohol. NIMH is interested in the comorbidity of
psychotic disorders and substance abuse. The VA and the Department of Defense have a
strong interest in alcoholism treatment. The Department of Transportation also has an
interest in alcoholism treatment because excessive alcohol use can affect safety on roads and
railroads, in sea lanes and rivers, and in the air. Insurance companies and state,
not-for-profit, and proprietary alcoholism treatment programs all have a stake in treatment
outcome research.
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~ Recent actions by the VA to curtail the availability of alcoholism treatment will
have a devastating impact on treatment research in the alcohol field. Given the high
percentage of veterans with alcohol-related pathology who are hospitalized on
medicaUsurgical units in VA hospitals, the committee recommends that the VA reverse
these actions and renew its commitment to alcohol treatment and treatment research.
· The program to use funds appropriated in the 1986 Anti-Drug Abuse Act to support
controlled trials of alcohol and cocaine treatment should be stabilized, extended, and used
as a model for the evaluation of all federally supported treatment initiatives. Similarly, the
recent decision to allocate a percentage of block grant funds to evaluation provides an
opportunity to advance carefully designed process and outcome evaluation as an integral
component of treatment programs supported by the federal government and implemented
at the state level. This initiative should be used to encourage cooperation between
academic and research institutions on the one hand and publicly supported treatment
programs on the other.
· Cooperative agreements should be implemented as a mechanism for funding
complex, multisite treatment outcome studies and clinical trials. NIAAA should be
provided with the personnel resources to provide proper staffing of these initiatives.
· NtAAA should encourage the inclusion of salary support on grants for clinical
facility personnel involved in treatment evaluation research as a means of encouraging the
participation of such facilities in treatment trials. Salary support should be identified on
individual grant proposals and within cooperative agreements.
· NIAAA should continue to highlight the state of the art in treatment research
studies by establishing and upgrading guidelines for quality designs and methods of
treatment research.
REFERENCES
Armor, D. J., J. M. Polich, and H. B. Stambul. Alcoholism and Treatment. New York:
John Wiley and Sons, 1978.
Fuller, R. K, L. Branchey, D. R. Brightwell et al. Disulfiram treatment of alcoholism.
A Veterans Administration cooperative study. J. Am. Med. Assoc. 256:1449-1255, 1986.
Institute of Medicine. Causes and Consequences of Alcohol Problems: An Agenda for
Research. Washington, DC: National Academy Press, 1987.
Lettieri, D., M. Sayers, and J. Nelson. Summaries of Alcoholism Treatment Assessment
Research. NIAAA Treatment Handbook Series~vol. 1. Washington. DC Government
Printing Office, 1984.
O , ~
Miller, W. R., and R. K Hester. Inpatient alcoholism treatment: Who benefits? Am.
Psychol. 41~7~:794-805, 1986.
Polich, J. M., D. J. Armor, and H. B. Braiker. The Course of Alcoholism: Four Years
After Treatment. New York: John Wiley and Sons, 1981.
Saxe, L., D. Dougherty, K Esty, and M. Fine. The effectiveness and costs of alcoholism
treatment. Health Technology Case Study 22. Office of Technology Assessment, U.S.
Congress. Washington, DC: Government Printing Office, 1983.
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Skinner, H. ~ Different strokes for different folks: Differential treatment for alcohol
abuse. Pp. 349-368 in Evaluation of the Alcoholic: Implications for Research, Theogr,
and Treatment. NIAAA Research Monograph No. 5. Rockville, MD: NIAAA, 1981.
Tims, F., and I. Ludford. Drug Abuse Treatment Evaluation: Strategies, Progress and
Prosper is. National Institute on Drug Abuse Monograph Series, vol. 51. Washington,
DC: Government Printing Office, 1984.
Yahr, H. T. A national comparison of public and private-sector alcoholism treatment
delivery system characteristics. J. Stud. Alcohol 49:233-239, 1988.
.
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Representative terms from entire chapter:
cooperative agreements
