Full Text DA-94-001


NIH GUIDE, Volume 22, Number 36, October 8, 1993

RFA:  DA-94-001

P.T. 34

  Drugs/Drug Abuse 
  Treatment, Medical+ 
  Biomedical Research, Multidiscipl 

National Institute on Drug Abuse

Letter of Intent Receipt Date:  December 17, 1993
Application Receipt Date:  January 18, 1993


Grant support from the National Institute on Drug Abuse (NIDA) is
available to establish Drug Dependence Research Centers (DDRCs).
DDRCs are defined in two categories: (1) Treatment Research Centers
(TRCs) or (2) Medications Development Research Centers (MDRCs).
DDRCs that primarily conduct interdisciplinary research on the
efficacy of treatment of drug dependence will be considered to be
Treatment Research Centers (TRCs).  DDRCs that primarily conduct
interdisciplinary research on medications development for drug
dependence will be considered to be Medications Development Research
Centers (MDRCs).  Applicants are expected to develop proposals that
are primarily TRC or MDRC in their integrative research theme, but
may choose to include components consistent with either category
(e.g., a TRC application may include project(s) that are medications
development or vice-versa).

The Drug Dependence Research Center Grant Program is designed to
complement the regular research grant program of NIDA by providing
long-term support for interdisciplinary drug dependence treatment
research.  The program is intended to attract clinical investigators
in the behavioral and medical sciences to conduct research designed
to (1) maximize the efficacy of behavioral and pharmacologic drug
dependence treatment or (2) pursue the identification and development
of pharmacologic interventions for drug dependence treatment.

One purpose of this program is to provide a stable environment for
investigators to engage in drug dependence treatment research.  Each
DDRC supported is expected to become a significant regional or
national research resource.


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 Request
for Applications (RFA), Drug Dependence Research Center Grants, is
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).


Applications may be submitted by domestic, 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.  However, the proposed
TRC or MDRC must be affiliated with an institution, such as a
university, medical center, or research center, that has the
resources to sustain a long-term, coordinated research program around
a central theme relating to maximizing and establishing the efficacy
of drug dependence treatment including medications development.  An
applicant institution must demonstrate the ability to attract high
quality scientists from biomedical, behavioral, and/or social science
disciplines who are willing to make a long-term commitment to drug
dependence treatment research.  The proposed TRC or MDRC should have
the clear capability to conduct clinical research in existing
treatment or medications development programs.  Applicants should
demonstrate explicitly how this research will be integrated within
the treatment program.  Applications from minority individuals and
women are encouraged.  Foreign organizations are ineligible.


The National Institutes of Health (NIH) center grant (P50) will be
the mechanism of support used under this RFA.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  This RFA is a one-time solicitation.
Any applications received after the receipt date will be returned to
the applicant without further review.

It is anticipated that up to $14 million will be available to support
the first year of this grant program.  Because the nature and scope
of the research proposed in response to this RFA may vary, the size
of an award will also vary.  However, it is anticipated that
approximately 8 to 10 new awards will be made under the RFA.  Many
promising treatment interventions cannot be readily studied due to
lack of availability of services necessary to provide comprehensive
treatment to research subjects.  In such cases research is only
possible if financial support is provided to support treatment-
related as well as research costs.  Under this announcement, support
may be provided to DDRCs for comprehensive treatment services
essential for carrying out the proposed research.

If required in support of research activities, funds may be expended
on drug abuse treatment costs, rental and operation of facilities,
approved renovation and modification of facilities (subject to limits
and conditions specified in Public Health Service grant policy), and
other costs normally allowable under existing Public Health Service
grants policy.  Funds may not be used for new construction or to
replace existing treatment funding.  In general, funds will not be
provided for the purchase and installation of expensive, new

For MDRCs, funds may be requested for subject accrual and
recruitment.  Once approved, however, reimbursement for patient
accrual is for this purpose only and may not be rebudgeted to other


This research program is intended to support the establishment of
DDRCs (TRCs or MDRCs) to conduct interdisciplinary research on the
efficacy of treatment for drug addiction.  Effort is to be made to
use state-of-the-science approaches.  Drug dependence treatment
efficacy research within a DDRC should involve the systematic
development and integration of knowledge derived from a variety of
sources and should utilize a number of designs.

The proposed research must be organized around a central theme.  The
theme of the DDRC (TRC or MDRC) should clearly relate to
investigating the efficacy of drug dependence treatments.  DDRCs
funded under this announcement may conduct research on:

1.  psychobehavioral treatments and/or
2.  currently marketed pharmacological treatments

3.  medications development

Applicants for DDRCs may include components in their applications for
both treatment and medications development research, but it is
expected that each will have a primary emphasis:  TRC or MDRC.

Treatment Research Centers (TRCs):

TRCs may investigate:

1.  the efficacy of psychotherapies, behavior therapies, and
counseling strategies for all phases of drug dependence treatment.
TRCs may also perform work on the development, refinement, and pilot
testing of such behavioral therapies;
2.  optimizing the efficacy of currently marketed pharmacotherapies
for drug dependence;
3.  the effects of ancillary services on therapy;
4.  the efficacy of well-defined comprehensive treatment approaches;
5.  psychobehavioral and neurobiological factors predictive of
treatment efficacy, including research aimed at identifying patient
characteristics that interact with the therapy or treatment provided;
6.  methodological issues related to the proposed clinical research.

TRC Research Themes

Possible TRC themes may include, but are not limited to, any of the
following research areas:

1.  Development and efficacy testing of psychobehavioral
interventions, complementary adjunctive services, or well-defined
comprehensive treatments for special populations of drug addicts,
such as: a.  Racial and ethnic minorities
b.  Adolescent drug abusers
c.  Addicted women, pregnant women and/or mothers
d.  Individuals at high risk for AIDS or HIV positive individuals e.
Dually diagnosed individuals

2.  Development and efficacy testing of psychobehavioral
interventions, complementary ancillary services, and explicitly
described comprehensive treatment approaches designed to:

a.  Treat specific drug dependence problems/patterns, such as IV drug
abuse or poly-drug abuse
b.  Enhance recruitment into treatment and motivation to achieve
sobriety, increase retention, and improve adherence with treatment
c.  Improve the ability of the drug addict to maintain gains made
during the acute treatment period (continuing care)
d.  Be integrated with and optimize the efficacy of currently
approved pharmacotherapies for drug dependence

3.  Investigations of marketed drug dependence pharmacotherapies for
particular populations of drug addicts, such as the dually diagnosed.

4.  Relationship of psychobehavioral and/or neurobiological factors
to therapy/treatment efficacy

Medications Development Research Centers (MDRCs)

MDRCs may emphasize the study and development of new
pharmacotherapeutic medications to:

1.  block the effects of abused drugs;
2.  reduce the craving for abused drugs;
3.  moderate or eliminate withdrawal symptoms;
4.  block or reverse the toxic effects of abused drugs; 5.  prevent
relapse in persons who have been detoxified from drugs of abuse;
6.  be used in special populations such as racial or ethnic
minorities, adolescent drug abusers, addicted women, or pregnant

Identified pharmacologic agents for the treatment of drug dependence,
primarily for the treatment of cocaine and opiate addiction, may be
assessed in clinical pharmacologic paradigms and/or in clinical
trials.  Such studies can include clinical pharmacologic assessments
including human laboratory assessments and/or clinical trials at one
or more sites designed to comply with Good Clinical Practice (GCP)
standards of the Food and Drug Administration (FDA).  Documentation
of GCP is available from the program officer of the MDRC.
Development and integration of new methods and technology for the
study of new pharmacotherapeutic agents for drug dependence treatment
are encouraged.  The range of studies envisioned can include:

1.  clinical concept confirmation studies;
2.  studies designed to address pharmacokinetic parameters; 3.
studies designed to assess conclusively (by appropriate methodology
and rigorous statistical analysis) questions of efficacy of new
potential pharmacotherapeutic agents for drug dependence treatment;
4.  studies that develop and evaluate rapid and efficient clinical
methods to predict efficacy of new pharmacologic agents to treat drug
5.  studies to develop methods that advance or improve the
development of new medications for drug dependence treatment.

MDRC Research Themes

MDRC applications can incorporate theme(s) from a range of clinical
pharmacologic and clinical trials topics.  Applicants are encouraged
to include studies that seek to:

1.  determine in both drug abusers and normal volunteers the
pharmacokinetic profile of a new or novel investigational agent with
available preclinical testing data for use in drug dependence
treatment including safety and toxicity profiles;

2.  evaluate in cocaine and opiate dependent patients the efficacy
and safety of new or novel investigational compounds with available
preclinical testing results;

3.  evaluate the combined efficacy of potential investigational
pharmacotherapeutic agents and other treatment parameters such as
behavioral interventions or cross subject comparisons.

4.  evaluate or develop laboratory parameters that may correlate with
or predict pharmacotherapeutic response;

5.  evaluate the potential abuse liability and effects on performance
of investigational compounds in cocaine and opiate dependent

6.  evaluate pharmacotherapy in selected populations of cocaine and
opiate dependent patients including neonates, adolescents, females
and HIV seropositives.

The major emphasis will be on clinical pharmacologic evaluations and
clinical trials, including clinical concept confirmation studies, to
evaluate the dose-response, efficacy and safety profiles for further
medication development.  These clinical trials can include studies
initiated by the MDRC as well as relevant multisite trials sponsored
by NIDA or pharmaceutical sponsors or both.  Applicants should
indicate their willingness to participate in such trials in letters
appended to their applications.


The applicant should provide a detailed plan (for up to five years)
describing the DDRC's proposed research program, focused on the
central theme.  This plan should include specific information on the
proposed research projects, identification of scientists who are to
be affiliated with the DDRC, and their roles in the program of
research.  Existing research programs and projects that are essential
to the plan should be identified and arrangements for integrating
these into the DDRC's activities delineated.  Letters of cooperation
should be obtained from Principal Investigators whose data will be
used in DDRC activity, except for those programs whose data bases are
in the public domain and routinely made available for public use.
Letters of cooperation will also be needed for multi-site
investigations where identified programs are to be used for control
or manipulation of variables.  The nature and mix of investigators
will be dependent on the particular theme selected.  However,
potential is seen for interrelated studies involving scientists in
the areas of clinical, counseling and experimental psychology,
medical specialties (including psychiatry), clinical pharmacology,
clinical toxicology, social work, and statistics as are relevant to
the theme of the application.  Relationship of individual
projects/studies to the core program should be clearly delineated.

There must be at least three scored projects and a core which
collectively meet the criteria for a Center.  There is no maximum
limit to the number or projects or cores, however, it must be
demonstrated that they are administratively manageable.

Upon initiation of the program, the Clinical and Experimental
Therapeutics Branch, Division of Clinical Research, and the Clinical
Trials Branch, Medications Development Division, NIDA, will sponsor
periodic meetings for TRCs and MDRCs to encourage exchange of
information among investigators who participate in this program, and
to stimulate collaboration.  Applicants should request additional
travel funds for one or two one-day meetings each year, to be held in
the Bethesda/Rockville Maryland area.  Applicants should also include
a statement in their applications indicating their willingness to
participate in these meetings.

Facilities and Environment

Each applicant must demonstrate that it has available adequate
laboratory, clinical, and office facilities suitable for carrying out
the objectives of the proposed DDRC program.  Components of the
treatment and/or medications development research facility should be
identified and arrangements for integrating clinical research into
the DDRC's facilities explicitly described.  Although not required,
it is desirable that sufficient contiguous space be committed to give
the DDRC a high degree of cohesion and visibility.  In addition,
adequate reference facilities that will afford access to the relevant
drug abuse literature must be readily available.  It is expected that
such reference facilities will be the primary repository of
additional reference materials that may be obtained through the DDRC.
Relevant support services and adequate data processing facilities
must also be readily accessible within or through the institution.
Reasonable assurances of such support must be included with the

Organization and Administration

An applicant must designate an individual to serve both as Principal
Investigator (PI) for the DDRC grant and Director of the DDRC.  This
person must have eminent scientific credentials and be capable of
providing the leadership essential to the success of the research
program.  The PI and Director of the DDRC will have overall
scientific responsibility, responsibility for planning and
coordination of the DDRC program, preparation of the budget and
oversight of expenditures, staff appointments, space allocation, and
other aspects of administration and operation of the DDRC.  This
individual will be responsible and accountable to the recipient
institution for the proper conduct of the DDRC program.  The
recipient institution is, in turn, responsible to the Public Health
Service for the performance and financial aspects of the grant
supported activity.  The PI will be responsible for assuring
interaction and collaboration among scientists conducting research
within the DDRC, in order to promote a concerted approach to the
research theme of the DDRC.  The PI will be invited to participate in
NIDA's periodic research coordination meetings.  The PI also will be
responsible for the direct monitoring of ongoing research and for
identifying (with the assistance of his or her colleagues) research
activities to be expanded or decreased and needs for additional
resources or reallocation of resources.

The applicant may also designate a DDRC Coordinator, who will be
responsible to the DDRC Director and provide assistance to the
Director in budget preparation, oversight of financial aspects, and
administrative duties essential to the smooth operation of the DDRC.

In order to ensure an institutional commitment for space, staffing,
and other resources essential to the DDRC, including active
collaboration with clinical leaders, a letter of commitment from the
applicant institution is required as part of the application.

A DDRC must be an identifiable organizational unit, and it must have
an administrative structure and lines of authority which will
facilitate coordination among DDRC personnel and assure maximum
accountability and efficiency in DDRC operations.  It is expected
that the nature of investigators' affiliations with the DDRC will
reflect the applicant institution's policies on appointments.

Research Training

While the primary function of each DDRC is the conduct of high
quality interdisciplinary research, an important, but non-mandatory,
component related to the DDRC and its research efforts is the
training of research personnel.  It is anticipated that efforts made
to produce well-trained drug dependence therapy researchers will
enhance the overall DDRC program.  The applicant institution must
give evidence of the capacity to train predoctoral and postdoctoral
students for careers in research on drug dependence.  The DDRC need
not have formal training programs of its own, but must make specific
provision for coordination between the DDRC and training programs of
the applicant institution and/or affiliated institution.  While DDRC
grant funds may not be used to pay stipends or other trainee costs,
DDRC staff may participate in the development of training programs
and DDRC resources may be made available for the use of trainees.
Applicants are encouraged to seek training support from other funding
sources within and outside NIDA.



Applications for clinical research grants and cooperative agreements
that involve human subjects are required to include minorities and
both genders 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
applies to all research involving human subjects and human materials,
and applies to males and females of all ages.  If one gender and/or
minorities are excluded or are inadequately represented in this
research, particularly in proposed population-based studies, a clear
compelling rationale for exclusion or inadequate representation
should be provided.  The composition of the proposed study population
must be described in terms of gender and racial/ethnic group,
together with a rationale for its choice.  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.

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 minorities populations (i.e., Native Americans
[including American Indians or Alaskan Natives], Asian/Pacific
Islanders, Blacks, Hispanics).  Investigators must provide the
rationale for studies on single minority population groups.

Applications for support of research involving human subjects must
employ a study design with minority and/or gender representation (by
age distribution, risk factors, incidence/prevalence, etc.)
appropriate to the scientific objectives of the research.  It is not
an automatic requirement for the study design to provide statistical
power to answer the questions posed for men and women and
racial/ethnic groups separately; however, whenever there are
scientific reasons to anticipate differences between men and women,
and racial/ethnic groups, with regard to the hypothesis under
investigation, applicants should include an evaluation of these
gender and minority group differences in the proposed study.  If
adequate inclusion of one gender and/or minorities is impossible or
inappropriate with respect to the purpose of the research, because of
the health of the subjects, or other reasons, or if in the only study
population available, there is a disproportionate representation of
one gender or minority/majority group, the rationale for the study
population must be well-explained and justified.

The NIH funding components will not make awards of grants,
cooperative agreements or contracts that do not comply with this
policy.  For research awards which are covered by this policy,
awardees will report annually on enrollment of women and men, and on
the race and ethnicity of subjects in the non-competing competitive


Prospective applicants are asked to submit, by December 17, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains allows NIDA staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857
Telephone:  (301) 443-2755

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91).  These forms are available at most institutional
offices of sponsored research and may be obtained from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone
(301) 710-0267.

The RFA label in the PHS 398 application kit must be affixed to the
bottom of the original face page.  Failure to use the RFA label and
to follow instructions could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition the RFA title and number must be typed in
Item 2a of the face page and YES box marked.

Submit a signed, typewritten original of the application, including
Checklist, and three signed photocopies in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857


Letter of Intent Receipt Date:  December 17, 1993
Application Receipt Date:       January 18, 1994
Initial Review:                 April 1994
Advisory Council:               June 1994
Earliest Award Date:            July 1, 1994

Applications received after the receipt date will be returned to the
applicant without review.


The Division of Research Grants, NIH, serves as a central point for
receipt of applications for most discretionary DHHS grant programs.
Applications received under this RFA will be assigned to a special
review group convened by the NIDA.  The review group, consisting of
experts in psychobehavioral and pharmacological drug abuse treatment
research, and medications development clinical trials, as warranted
by the applications, will review the applications for scientific and
technical merit in accordance with the standard NIH peer review
procedures.  Pre-review site visits will not be made, and
applications may not be deferred for site visit; therefore,
applications must be complete when submitted. 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 Advisory Council, whose review may be based on policy
considerations as well as scientific merit.  Only applications
recommended for further consideration by the initial review group and
Council may be considered for funding.

The review criteria are:

1.  Program as an Integrated Effort

o  The significance of the overall program goals and the development
of a well-defined central research focus of importance and relevance
to the goals and mission of NIDA.

o  The multidisciplinary or multifaceted character of the program,
i.e., its coordination, cohesiveness, interrelationship of the
components and relationship to the central theme, and synergistic
potential among the individual projects and core.

o  The justification for, and usefulness of the core facilities to
the research projects.  Each core unit must provide essential
facilities or services for three or more approved individual

o  The scientific stature of the investigators and the extent to
which each contributes to the overall program goals as well as their
commitment to the program.

o  Capacity to provide a variety of quality training opportunities.

o  Potential of the proposed DDRC to become or continue as a regional
and national resource as appropriate to research objectives of this

o  Administrative arrangements and organizational structure, through
the administrative core, to facilitate and monitor the attainment of
objectives and internal quality control.  For example, these factors
will include plans to enhance communication and cooperation among the
investigators involved in the program and mechanisms for the
allocation of funds for day-to-day management, long-term planning and
periodic evaluation, contractual agreements, and procedures for the
replacement of key personnel, e.g., the Principal Investigators, if
required on an interim or permanent basis.

o  Reasonableness of the overall budget for the proposed work.

o  In addition, applications from currently funded grantees who are
applying for competing continuation support under this RFA will be
evaluated in terms of the degree to which they have achieved the
originally stated goals, with special attention to the following: the
scientific merit of completed research, implementation of innovative
research areas, recruitment of new scientists into drug abuse
research and the training of young scientists, development of a
multidisciplinary research team, coalescence of the Center staff into
an effective team, and increase of professional and public awareness
of drug abuse problems.
2.  Individual Projects and Core Units

o  The scientific and technical merit of each research project, merit
and justification of each core unit.

o  The qualifications, experience, and commitment of the
investigators responsible for the research projects or core units,
including their ability to devote adequate time and effort to the

o  The appropriateness of the budget for each of the proposed
projects and core units.

3.  Resources and Environment

o  The academic climate and physical environment in which the
research will be conducted, including the availability of space,
equipment, research subjects, etc., and the potential for interaction
with scientists from other departments and/or institutions.

o  Adequacy of the clinical and research facilities to perform the
proposed research including access to subjects, instrumentation, and
data management systems when needed.

o  The institutional strength, stability, and commitment to research
and support for the proposed Center and its ability to attract highly
qualified scientists.


Applications recommended for further consideration by an National
Drug Abuse Advisory Council will be considered for funding on the
basis of overall scientific and technical merit of the application as
determined by peer review, appropriateness of budget estimates,
program needs and balance, policy considerations, adequacy of
provisions for the protection of human subjects, and availability of
funds.  Funding for the MDRC applications will also be considered on
the basis of: (1) demonstrated ability to comply with FDA guidelines
for Good Clinical Practice (GCP) and (2) demonstrated capacity to
recruit evaluable patients and submit acceptable data in appropriate
time frames to permit optimal analysis of clinical trial results.

The anticipated date of award is July 1, 1994.


Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applications is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Jack Blaine
Division of Clinical Research
National Institute on Drug Abuse
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4060

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710


This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under authorization of the
Public Health Service Act, Sections 301 and 464P, and administered
under PHS grants 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.


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