RESEARCH PROGRAM TO IMPROVE DRUG ABUSE TREATMENT

NIH GUIDE, Volume 22, Number 30, August 20, 1993



PA NUMBER:  PA-93-100



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Treatment, Medical+ 



National Institute on Drug Abuse



PURPOSE



The purpose of this Program Announcement is to encourage research on

interventions to improve drug abuse treatment.  The aim of the grant

program is to demonstrate improvements in drug abuse and dependence

treatment, resulting in a greater range of effective, standard

treatments enabling treatment systems to operate with greater

effectiveness and efficiency.



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, Research Program to Improve Drug Abuse Treatment, 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 domestic and foreign for-profit and

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

colleges, hospitals, laboratories, units of State or local

governments, and eligible agencies of the Federal Government.  Women

and minority investigators are encouraged to apply.



MECHANISM OF SUPPORT



The mechanism available for support of this program announcement is

the research project grant (R01).  In fiscal year 1994, it is

estimated that $10 million will be available from the National

Institute on Drug Abuse (NIDA) to support approximately 15 new grants

under this announcement.



RESEARCH OBJECTIVES



Increasing the effectiveness of drug abuse treatment through research

is one of the primary goals of NIDA.  Effective treatment is

essential to efforts to reduce the demand for illicit drugs.  The

importance of this goal has been underscored by the Acquired

Immunodeficiency Syndrome (AIDS) epidemic, since effective treatment

is critical to preventing the spread of the Human Immunodeficiency

Virus (HIV) among injecting drug users.



This program announcement establishes a research program to improve

drug abuse treatment in accord with recommendations from the

five-year treatment research planning process.  The intent of the

research grant program is to improve existing treatment strategies.



Description of the Program.  Applications submitted under this

announcement should focus on improving existing treatment approaches,

developing new treatment approaches, or addressing important clinical

questions impacting on treatment outcome.  Interventions may be based

in a variety of settings (e.g., hospitals, residential programs,

outpatient programs, correctional settings).  Investigation into all

types of treatment modalities is encouraged.  Research projects that

investigate the effectiveness of different service components and

service strategies are of particular interest.  Additionally,

programs testing the independent and joint effects of marketed drug

dependence pharmacotherapies and psychobehavioral treatment

components for particular populations of drug addicts, such as the

dually diagnosed, are encouraged.



Applicants may establish new treatment slots with the funds

requested, in support of their research objectives.  In addition,

funds may be used to support service components to enhance treatment

outcomes (e.g., vocational rehabilitation as part of the treatment

provided), but the provision of services must be clearly related to

research objectives.



Research Projects.  Investigators are encouraged to use the most

rigorous methodology consistent with the purposes of the research.



Some research proposals may appropriately be studied through

experimental designs involving random assignment of subjects to

treatments, yet, such strategies may not be appropriate for all

circumstances.



Examples of research areas to be studied include, but are not limited

to, the following:



o  More effective outreach and recruitment strategies for treatment

entry and engagement.  Community-based interventions that forge

therapeutic alliances with families, social networks, and community

organizations need to be formulated and tested, especially for the

substantial minority of drug users who will not enter drug abuse

treatment.



o  Research to improve treatment engagement and retention.



o  Therapy-specific diagnostic methods of defining drug abuse

syndromes that assess problems addressed by specific therapeutic

alternatives and matching individual patient characteristics with

treatment techniques.



o  Research on outpatient treatment retention and compliance,

addressing the serious problem of continued use of alcohol,

marijuana, cocaine, and benzodiazepines by patients in treatment for

other drugs of abuse.



o  Research to investigate and maximize the efficacy of individual

and group, behavioral, cognitive-behavioral, psychodynamic, family

therapy, brief interventions, and interpersonal therapies.



o  Use of existing behavior modification methods to compensate for

cognitive deficits in drug addicts is of particular interest.



o  Drug counseling techniques, operationally defined, to permit the

investigation of their efficacy.



o  Outreach strategies to encourage treatment reentry and/or provide

alternative community-based interventions for patients who drop out

of treatment.



o  The impact of ancillary and specialized services, such as literacy

training, vocational training and employment services, housing

assistance, primary health care, reproductive counseling, parenting

training, and case management on treatment engagement, retention, and

drug abuse treatment outcomes.



o  AIDS-related treatment research within existing programs,

including medical and case management services for infected and ill

clients, grief counseling for clients and staff, AIDS prevention

counseling, sexual and perinatal transmission, etc.



o  Considering the danger of HIV infection with relapse to drug use,

new extended treatment programs or aftercare strategies for

maintaining prolonged therapeutic interventions, supervision, and

support for clients need to be established to prevent relapse and

protect individuals.



o  Means of linking primary medical care with drug abuse treatment in

improving drug treatment outcomes especially for drug dependent

persons who have serious concomitant medical problems.



o  Research on models for integrating treatment of drug abuse and

other co-occurring psychiatric and neurological disorders.



o  Psychosocial and behavioral treatments for use in combination with

pharmacotherapies to address the problem of continued drug dependence

and that interfere with treatment engagement and compliance with

medication regimes.



o  Adaptation and assessment of existing treatments that have been

found generally effective, for specific racial and ethnic groups.



o  Studies of interventions that specifically address the unique

needs of women (e.g., interventions that emphasize interpersonal

relationships, that address sexual abuse or other forms of

victimization).



o  Treatment research on youth who begin drug use at an early age,

are school dropouts, and are at risk for later drug dependence.



o  Intensive and multi-component interventions for difficult-to-treat

clients, low-income persons caught in the cycle of poverty, poorly

educated clients who may be functionally illiterate, psychiatrically

impaired or lacking in vocational skills.



All applicants are strongly encouraged to address issues of project

feasibility, implementation of the intervention, study design,

sampling procedure, instrumentation and measurement, data collection,

tracking of clients, follow-up, and data analysis, as appropriate.

The applicant also may wish to include an information dissemination

plan, to assure that research findings are communicated to the

treatment field in a timely, efficient fashion.  Applicants are

advised to provide adequate information regarding available

facilities and staff, as well as plans to acquire new staff.



Investigators are encouraged to offer HIV testing and counseling in

accordance with current guidelines to subjects identified during the

course of the research as being at risk for HIV acquisition or

transmission.  In high-risk populations, investigators are encouraged

to assess the effects of new interventions on the acquisition and

transmission of infectious diseases, including HIV.



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.  Applicants who are currently supported under the NIDA

research demonstration program (R18) will be considered competing

continuation (type 2) R01 and may submit their applications for the

competing continuation receipt dates of November 1, March 1, or July

1.



Application kits are available at most institutional offices of

sponsored research and from the Office of Grants Information,

Division of Research Grants, National Institutes of Health, Westwood

Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267.  The

title and number of the announcement must be typed in item 2a of face

page of the application.



The completed original application and five legible copies must be

sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, Maryland 20892**



REVIEW CONSIDERATIONS



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

for receipt of applications for most discretionary DHHS 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.



AWARD CRITERIA



Applications recommended for further consideration by an appropriate

National Advisory Council will compete for available funds with all

other approved applications assigned to the appropriate Institute.

The following will be considered in making funding decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Institute program needs and balance



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.

Division of Clinical Research

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-30

Rockville, MD  20857

Telephone:  (301) 443-4060



Direct inquiries regarding fiscal issues to:



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

Section 301 of the Public Health Service Act (42 USC 241) and

administered under PHS policies and Federal Regulations at Title 42

CFR 52 "Grants for Research Projects,"  Title 45 CFR Part 74 and 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,

(revised 10/90), which may be available from your office of sponsored

research.



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