RESEARCH TO IMPROVE DRUG ABUSE TREATMENT ENTRY, RETENTION, COMPLIANCE,AND EFFECTIVENESS



NIH GUIDE, Volume 21, Number 44, December 11, 1992



PA NUMBER:  PA-93-28



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Rehabilitation/Therapy, Emotional 

  Behavioral/Social Studies/Service 



National Institute on Drug Abuse



PURPOSE



The purpose of this announcement is to encourage research to

investigate entry, retention, and compliance in drug abuse treatment,

and research on strategies to improve entry and retention in treatment,

and to bring about compliance with program expectations and

effectiveness of drug abuse treatment.  An important focus of these

studies will be on the various environmental and intrapersonal factors

that promote drug abuse treatment entry, retention, compliance, and

effectiveness.  Research may be conducted in conjunction with clinical

trials, evaluation studies, or through separate epidemiological and

ethnographic studies.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of Healthy People 2000, a

PHS-led national activity for setting priority areas.  This Program

Announcement (PA), Research to Improve Drug Abuse Treatment Entry,

Retention, Compliance, and Effectiveness, is primarily related to the

priority area of alcohol and other drugs.  Potential applicants may

obtain a copy of Healthy People 2000 (Full Report:  Stock No.

017-001-00474-0, or Summary Report:  Stock No. 017-001-00473-1) through

the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, non-profit and

for-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal Government.  Women

and minority investigators are encouraged to apply.  Foreign applicants

are not eligible for the First Independent Research Support and

Transition (FIRST) awards (R29).



MECHANISM OF SUPPORT



Mechanisms available for support of this program include individual

research applications (R01s), FIRST awards (R29s), and small grants

(R03s).  Small grants (R03s) and FIRST awards (R29s) may not apply for

a renewal (competing continuation) of the project.  For details on a

particular support mechanism or program, contact the program staff

listed under INQUIRIES.



RESEARCH OBJECTIVES



The treatment of drug abuse and addiction is a key part of the

President's national drug control strategy.  Two factors significantly

affecting treatment outcomes are the length of time spent in treatment

and the patient's during-treatment performance.  Given the adverse

health and other consequences of drug use and the scarcity of treatment

resources, it is imperative that treatment effectiveness is improved by

increasing patient retention and improving patient compliance with

treatment.



The amount of time spent in treatment is one of the most significant

predictors of favorable treatment outcomes.  Research has shown that

patients under legal sanction are likely to stay in treatment longer.

Research has also addressed compliance with treatment expectations.

Provision of enhanced services to treatment patients has also been

shown to improve outcomes.  Recent research has found that setting

behavioral contingencies for take-home methadone privileges is an

effective means of improving compliance with program expectations.  As

with other chronic diseases, there are compliance issues that interact

with medication and behavior.  Given high demand for drug abuse

treatment relative to existing capacity and the need to improve drug

abuse treatment outcomes, this announcement seeks to stimulate research

projects that will increase knowledge about treatment compliance and

retention.



Description of Program



Applications submitted under this announcement should focus on (1)

research to understand factors and processes related to patient

retention in treatment or compliance with program expectations; (2)

research to test treatment innovations or strategies to enhance the

ability of programs to retain patients or increase rates of program

completion; and/or (3) strategies to improve patient compliance with

program rules, expectations, and treatment goals.  Studies under this

announcement may involve analyses of existing data bases, collection of

new data in programs, development and testing of identification and

assessment methodologies to improve retention and compliance, or

program-based studies of strategies for improvement in these areas.

Investigation is encouraged in all treatment modalities (including

methadone maintenance, medically supervised withdrawal from methadone

with transition to counseling or self-help programs, drug-free

outpatient, and therapeutic community or short-term

residential/inpatient programs), although short-term treatment should

be effectively linked to aftercare or continuing care arrangements.

Compliance strategies that address aftercare are encouraged.



Studies of interventions may be comparative or controlled studies, but

should utilize the best available and most appropriate research

methodologies.  Controlled studies should be based on well-defined

patient groups entering treatment and treatment models that take into

account identifiable stages of treatment at which program modifications

are most likely to be needed in order to increase retention and

compliance. Interventions can be pharmacological or nonpharmacological

and may be based in a variety of settings (e.g., hospitals, residential

programs, outpatient programs, correctional settings).



Retention in treatment.  Although research has shown that successful

outcomes are more likely if patients stay in treatment for 90 days or

longer, early dropout rates in many drug abuse treatment programs are

high.  Research focused on studies of retention in treatment and

strategies to improve retention, such as tailored interventions to

reduce dropout in the critical induction period, is needed, as are

studies to clarify the relationship between length of treatment and

treatment outcome.  Also of interest are studies to determine the roles

of legal coercion, social supports and/or pressure, and other external

factors that influence retention in treatment.



Compliance in treatment.  Research indicates that during-treatment

performance is predictive of post-treatment outcomes.  New studies to

examine strategies to improve treatment performance by reducing

problematic use of alcohol and other drugs, by improving participation

in treatment, or by improving compliance with other treatment program

goals are encouraged.  Investigations may also focus on improving the

operation or organization of treatment programs to increase compliance

and retention.



Studies may be of single interventions such as behavioral

contingencies, combinations of interventions, program structure

interventions combining targeted services and behavioral contingencies,

and/or the use of medications in conjunction with program structure.

Examples of program structure factors include negotiation of behavioral

expectations (e.g., job search, participation in training), monitoring

program-relevant behavior, participation in individual and group

counseling or therapy as a condition for remaining enrolled in

treatment, tracking and outreach to reduce treatment dropout, and

linking social incentives such as social services or job

training/placement to treatment enrollment and participation.



Strategies to increase compliance may include improving the

staff/patients therapeutic relationship, assessing and meeting patient

needs (e.g., medical/dental care, child care), improving the

effectiveness of drug abuse counselors in meeting patient needs, and

pharmacological and behavioral strategies alone or in combination.

Investigators may wish to consider compliance strategies in patient

subgroups based on diagnostic criteria and stages of recovery.

Research that examines fundamental questions of program philosophy and

patient-treatment interactions (including matching) are encouraged.



Specific Areas of Interest



Research priorities include the need to characterize better the

individuals who stay in or leave treatment, to examine the decision

process leading to remaining in treatment, and to assess program

factors that may inhibit or facilitate treatment compliance.  Also

relevant are the potential influences of concurrent psychiatric and

other medical disorders (e.g., AIDS) on treatment retention and

compliance.



Research is needed on how patient personality, perceptions,

expectations, and beliefs affect treatment retention and the effect of

program organization, leadership, and context on the retention process.

The role social networks play in the decision to remain in treatment

and in compliance with treatment also should be explored.



Since drug dependence is a chronic relapsing disorder, more needs to be

learned about persistent drug-induced neuropsychological changes that

may be involved in leaving treatment or failures to comply with

treatment.  Also, there should be study of the effects of drug

availability and other environmental factors on retention.



To clarify intrapersonal and environmental factors associated with

treatment retention and compliance, studies of untreated drug dependent

persons, as well as those in treatment, are strongly encouraged.  Thus,

epidemiological and ethnographic studies are needed to complement what

can be learned through studies of interventions.  Research on the

natural history of drug disorders should be particularly helpful in

clarifying the role of a variety of treatments in retention as well as

factors associated with compliance.  To facilitate this research,

methodological approaches for assessing the long-term course of drug

disorders need to be refined.



Archival and secondary analyses are encouraged to exploit the potential

of existing data sets.  Development of compatible data bases across

programs are encouraged to facilitate replication across settings, with

different populations, and over time.



Examples of research areas identified above include the following:



o  Factors associated with treatment retention and compliance (e.g.,

patient personality, perceptions, expectations, and beliefs) should be

explored explicitly in treatment research studies.  Comorbidity studies

could be informative.



o  The role of social networks in affecting treatment retention and

compliance should be studied.  Examination of gender, ethnic, and

educational differences and examination of differences in social

competence are particularly important.



o  The characteristics of individuals who stay in or leave treatment

should be studied to determine how they differ and possible ways in

which those who leave treatment can be induced to remain in treatment.

The decision-making process leading to decision to leave

treatment--including the roles of factors such as drug- related

neuropsychological deficits, family members, and coercion in deciding

to seek treatment--should be studied.



o  Treatment retention failures should be studied to determine why

treatment retention does not occur.  This should include why persons

fail to invest in treatment.



o  The effect of program organization, leadership, and context on

treatment retention should be studied.  Research should include

studying the impact of program type (e.g., directive-nondirective,

medical-nonmedical orientation, residential-nonresidential), perceived

staff caring (the so-called "smile factor"), and cultural aspects of

the program (race, ethnicity, language) on retention.



o  Better methods to assess and evaluate the probability of leaving

treatment are needed (e.g., employing measures of drug craving, drug

availability, stage(s) in drug abuse history, cognitive deficits,

availability of support systems).



o  Neuropsychological factors, including those that are drug induced,

may increase the likelihood in some persons to leave treatment and

these factors should be studied.  Cognitive deficits of drug abusers in

treatment may preclude treatment compliance and their role in the

treatment retention process needs to be assessed.



Cross-Institute/Intra-Institute Areas of Interest



Projects may be submitted under this announcement that address issues

in common with, for example, the National Institute on Alcohol Abuse

and Alcoholism (NIAAA), the National Institute of Mental Health (NIMH),

and various programs within NIDA.  Also, applicants may wish to

collaborate with the Center for Substance Abuse Treatment (CSAT) or the

Center for Substance Abuse Prevention (CSAP) grantees who deal with the

types of environmental and social factors addressed by this

announcement.  It is conceivable that an applicant could carry out the

research in the context of a CSAP Community Partnership grant, a CSAT

Target Cities grant, a CSAP High Risk Youth grant or other initiative.

This would have the benefit of providing a potential applicant with a

pool of patients and a primed community.  Preapplication consultation

with the individual listed below is strongly encouraged.  Applications

are considered for acceptance and assigned according to standard

NIH/PHS referral guidelines.



International Comparative Studies



It is recognized that some treatment research issues related to such

areas as retention in treatment, program completion, and compliance

with treatment expectations lend themselves to comparative multi-site

study, especially where environmental differences and available

treatment options are concerned.  Well-designed comparative multi-site

studies may include program sites in foreign countries, provided that

the foreign program site is justified in terms of the research

objectives.  Such studies may include a collaborating scientist or

clinical researcher affiliated with the foreign program sites.

However, foreign institutions are not eligible for FIRST awards (R29s).



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements will be required to include minorities and women

in study populations so that research findings can be of benefit to all

persons at risk of the disease, disorder or condition under study;

special emphasis should be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to apply

to males and females of all ages.  If women or minorities are excluded

or inadequately represented in clinical research, particularly in

proposed population-based studies, a clear compelling rationale should

be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information should be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Subjects.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However, NIH

recognizes that it may not be feasible or appropriate in all research

projects to include representation of the full array of United States

racial/ethnic minority populations (i.e., Native Americans (including

American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,

Hispanics).



The rationale for studies on single minority population groups should

be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.



All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted at the standard application deadlines

as indicated in the application kit.  The receipt dates for

applications for AIDS-related research are found in the PHS 398

instructions.



Application kits are available at most institutional offices of

sponsored research and from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building, Room

449, Bethesda, MD 20892, telephone 301/496-7441.  The title and number

of the announcement must be typed in Item 2a of face page of the

application.



FIRST award applications must include at least three sealed letters of

reference attached to the face page of the original application.  FIRST

award applications submitted without the required number of reference

letters will be considered incomplete and will be returned without

review.



The completed original and five permanent, legible copies of the PHS

398 form must be sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



The Division of Research Grants (DRG), NIH, serves as a central point

for receipt of applications for most discretionary HHS grant programs.

Applications received under this announcement will be assigned to an

initial review group (IRG) in accordance with established PHS referral

guidelines.  The IRGs, consisting primarily of non-Federal scientific

and technical experts, will review the applications for scientific and

technical merit in accordance with the standard NIH peer review

procedures.  Notification of the review recommendations will be sent to

the applicant after the initial review.  Applications will receive a

second-level review by an appropriate national advisory council, whose

review may be based on policy considerations as well as scientific

merit.  Only applications recommended for further consideration by the

council may be considered for funding.  Small grants (R03s) do not

receive a second level review.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to the Institute/Center/Division.  The following

will be considered when making funding decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Frank M. Tims, Ph.D.

Treatment Research Branch

Division of Clinical Research

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-30

Rockville, MD  20857

Telephone:  (301) 443-4060



Direct inquires regarding fiscal issues to:



Mrs. Shirley A. Denney

Chief, Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.279.  Awards are made under authorization of the Public Health

Service, Sections 301 and 405, and administered under PHS policies and

Federal Regulations at Title 42 CFR 52, Grants for Research Projects,

Title 45 CFR Part 74 & 92, Administration of Grants, and 45 CFR Part

46, Protection of Human Subjects.  Title 42 CFR Part 2, Confidentiality

of Alcohol and Drug Abuse Patient Records may also be applicable to

these awards.  This program is not subject to the intergovernmental

review requirements of Executive Order 12372 or Health Systems Agency

review.



Sections of the Code of Federal Regulations are available in booklet

form from the U.S. Government Printing Office.



Grants must be administered in accordance with the PHS Grants Policy

Statement, (rev. 10/90), which is available from institutional offices

of sponsored research.



.

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