Release Date:  May 25, 1999 (see replacement PA-03-066)

PA NUMBER:  PA-99-107

National Institute on Drug Abuse


This program announcement replaces in its entirety PA-94-078, Behavioral
Therapies Development Program, published in the  NIH Guide, Vol. 22, No. 26,
July 15, 1994.

The purpose of this program announcement (PA) is to reaffirm National
Institute on Drug Abuse's (NIDA) continued and ongoing commitment to a major
program of research on behavioral therapies for drug abuse and dependence. 
The term "behavioral therapy" is used here in a broad sense and includes
various forms of psychotherapy, behavior therapy, cognitive therapy, family
therapy, skills training, counseling, and other rehabilitative therapies. 
Behavioral therapy research has been conceptualized, for the purposes of this
initiative, to consist of three stages.  Stage I, or early therapy
development, involves research on the development, refinement, and pilot
testing of behavioral interventions.  Stage I includes research aimed at
translating basic behavioral and cognitive research into novel behavioral
therapies.  Stage II involves the efficacy testing of therapies that show
promise and includes research on the hypothesized mechanisms through which
these therapies may have their effect.  Stage III is research aimed at
determining if and how efficacious behavioral therapies may be transported to
community settings, including primary care sites.  Stage III includes research
examining methods of training therapists and counselors to administer new
behavioral therapies.


The Public Health Service 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 RFA 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) from the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800)
or electronically (


Applications may be submitted by domestic and foreign, for-profit and
nonprofit organizations, public and private; such as, colleges, universities,
hospitals, laboratories, units of State and local government, and eligible
agencies of the Federal Government.  Racial/ethnic minority individuals, women
and persons with disabilities are encouraged to apply as Principal
Investigators.  Awards to foreign institutions under other research (R-series)
mechanisms are generally limited to 3 years.


Research support mechanisms include the National Institutes of Health (NIH)
research project grants (R01), exploratory/developmental grant (R21), and
small grant (R03). In addition, investigators may be eligible to apply for a
competitive supplement to add a research component to an existing grant.

Exploratory/developmental (R21) applications are limited to 3 years and small
grant applications are limited to 2 years, non-renewable, and limited in
direct cost amount per year (R03, $50,000; R21, $100,000).  The R03 mechanism
is intended for newer, less experienced investigators, for investigators at
institutions without a research tradition, or for experienced investigators
wishing to change research directions or test new methods or techniques.  The
R21 mechanism is intended to encourage exploratory research projects with
sound methodology and strong rationales in underdeveloped research areas. 
Specific information on individual research mechanisms can be obtained from
the NIDA home page at:

The competitive supplements will be reviewed in accordance with NIH standard
review procedures; i.e., peer review/Council review.

Beginning with the June 1, 1999 receipt date, "MODULAR GRANT APPLICATION AND
AWARD" procedures will apply to all competing individual research project
grants (R01), small grants (R03), and exploratory/developmental grants (R21)
applications requesting up to $250,000 direct cost per year (see the NIH
Guide, December 15, 1998).  Applications requesting more than $250,000 in any
one year must use the standard PHS 398 application instructions.

APPLICATION PROCEDURES to reflect the process which has been adopted by the
NIH.  More detailed information about modular grant applications, including a
sample budget narrative justification pages and a sample biographical sketch,
is available via the Internet at url:


Background and Rationale.  Behavioral therapies are frequently the only
treatments available to drug-dependent individuals.  Even where medications
are available, behavioral therapies can be an integral component of treatment. 
Recognizing the importance of behavioral therapies, NIDA has been supporting
research in this area through the Behavioral Therapies Development Program
(BTDP).  The BTDP is intended to promote all of the necessary stages of
behavioral therapy research so that new and more efficacious behavioral
therapies are developed as advancements in cognitive and behavioral science
are made, and so that the best behavioral therapies may be effectively
transported to the community treatment provider.  It is NIDA's intention to
support scientifically-sound and clinically-relevant behavioral therapy
research that will have a meaningful impact on improving the efficacy of drug
abuse/dependence treatment.  This initiative targets for funding, in a
systematic way, essential research on behavioral therapies for drug abuse and
dependence.  This includes, in particular, critical areas of research that
have been overlooked in the past.

Research indicates that many behavioral therapies for drug abuse and
dependence are efficacious. However, no therapy has been shown to be
completely efficacious for every individual.  For many individuals, engagement
and retention in treatment and relapse following treatment remain concerns. 
NIDA has undertaken the Behavioral Therapies Development Program with the goal
of addressing these concerns and substantially improving, for each individual,
the efficacy of behavioral therapies for drug abuse and dependence.

NIDA's Behavioral Therapies Development Program delineates three stages of
behavioral therapy research.  Stage I, the earliest stage of behavioral
therapy development research, is viewed as an iterative process involving
identifying promising clinical, behavioral, and cognitive science relevant to
treatment, generating and formulating new behavioral therapies, operationally
defining the therapies in manuals, and pilot testing and refining the

Stage II research consists of efficacy testing of promising therapies
identified in Stage I.  Stage II may also involve studies examining the
efficacy of components of therapies and studies examining individual
differences in response to the therapies.  Most of the behavioral therapy
research that NIDA has supported in the past has been of this type.  Stage II
also involves the replication, at other sites, of efficacy studies with
positive results.

Stage III research is aimed at understanding if and how an efficacious therapy
may be transported to the community. That is, one question relevant to Stage
III research is whether a therapy maintains its potency when it is
administered within community-based treatment programs.  Another question
relevant to Stage III research is the question of how therapists and
counselors can be trained to administer a new therapy effectively.  Thus,
Stage III research may involve the development of training procedures and
techniques to help teach therapists and counselors how to utilize new
therapies, and testing the utility of these procedures and techniques.

So that scientific knowledge will readily be incorporated into newer and more
efficacious behavioral interventions, and so that therapies are effectively
transported from research to the community, it is NIDA's objective to ensure
sufficient emphasis and support for all stages of behavioral therapy research. 
This PA is intended to promote this initiative by encouraging research grant
applications in any one of the three stages of behavioral therapy research.


This PA is intended to support all types of research on behavioral therapies
for drug abuse and addiction.  This includes, but is not limited to behavioral
therapy research on:

o  Therapies to treat abuse or addiction to understudied drugs including but
not limited to marijuana, methamphetamines, sedative-hypnotics, prescription
psychoactive drugs, inhalants, and hallucinogens, as well as more commonly
studied drugs including but not limited to heroin, cocaine, and nicotine.

o  Therapies for smoking cessation, specifically adapted for youth, that can
be utilized alone or in conjunction with nicotine replacement therapies.

o  Therapeutic interventions that can be added to enhance an existing
behavioral therapy.

o  Components or elements of behavioral therapies.

o  Therapies to be utilized in conjunction with medications, or behavioral
interventions to increase compliance with medication regimens.

o  HIV risk-reduction interventions that can be implemented in conjunction
with other therapeutic services.

o  Therapies for individuals with co-occurring drug and mental or other health

o  Therapies that address the unique needs and perspectives of women,
minorities, families, specific cultural groups, children, early or pre-
adolescents, and adolescents.

o  Therapies for use in primary care, criminal justice, and welfare system
o  Outreach therapies to out-of-treatment drug users to enhance their
motivation and facilitate their entry and retention in treatment, including
outreach approaches in primary care settings.

o  Adequate "dosage" of specific types of behavioral therapies for particular

Stage I, Stage II, and Stage III grant applications are encouraged in these
and other areas of behavioral therapy research for drug abuse and addiction. 
Additional information regarding Stages I, II, and III is provided below.

Stage I Research.  Investigators are encouraged to submit applications to
develop new or to modify existing individual, group or family behavioral
therapies for drug abuse or dependence, and to pre- or pilot-test the
therapies.  Applications are encouraged to develop therapies that have a
strong theoretical basis or logical rationale and are based in new
developments in the behavioral and/or cognitive sciences.

Applicants are encouraged to explicitly describe the theoretical basis for the
proposed therapy, the scientific basis for the therapy being proposed, and the
population for whom it is intended.  A general description of the nature of
the therapy/intervention being proposed and the plans for manualization of
this therapy/intervention are also encouraged.  If proposing a behavioral
intervention that is intended to be added to a specific existing therapy for
which a therapy manual exists, applicants are requested include a copy of this
therapy manual in their appendix materials, following the instructions for
appendices in the PHS 398 application kit.  Applicants are also encouraged to
propose testing of the hypothesized effects of the therapy, and may seek
support, as appropriate, under this announcement to develop measures of these
effects.  Where adequate measures do not exist, applicants may propose to
develop measures of therapist competence and adherence, process measures, and
instruments measuring the integrity and fidelity of the therapy.

In the development of a new therapy for drug dependence, a broad range of
issues relevant to efficacy and safety are raised. Pre- or pilot-testing is
considered an integral part of the therapy development process.  Therefore,
applicants are encouraged to describe the nature of any pre- or pilot-testing
intended.  Depending upon the scientific question being asked, a variety of
research designs may be appropriate for Stage I research, including single
case designs and studies involving random assignment of subjects to

Although one goal of a Stage I project is to proceed to Stage II, another goal
is to obtain scientific knowledge about behavioral processes that lead to
behavior change.  Because the early therapy development process is an
inherently exploratory process, immediate movement from Stage I to Stage II is
not always possible or desirable.  For example, an investigator may not be
able to conduct a pilot study warranting movement to Stage II because of
feedback necessitating changes in the therapeutic intervention during the
pilot.  In this case, although the Stage I investigator may not have acquired
the pilot data to warrant a larger-scale Stage II efficacy study, the Stage I
investigation may have produced valuable scientific information about behavior
change that could lead to another successful Stage I study.  Stage I may be
conceptualized as having multiple phases.  Early Stage I, or "Stage Ia" can be
viewed as the most exploratory part of the Stage I process, in which the
critical therapy development groundwork is laid.  Late Stage I or "Stage Ib,"
although still exploratory, can be viewed as the phase of Stage I in which a
pilot study is conducted that determines effect size, and is compelling enough
to warrant progression to Stage II.  Where scientifically warranted, it is
acceptable to submit competing continuation applications of Stage I research
when further development is indicated.

Stage II Research.  Stage II research establishes the efficacy of behavioral
therapies or therapy components shown to be promising in Stage I.  Stage II
research examines if therapies work, but also examines why therapies work, and
for whom therapies work.  Such research may examine any type of behavioral
therapy for drug abuse or addiction, including behavioral therapies that are
used in conjunction with medications.

Proceeding to Stage II presumes that promising Stage I pilot data exist.  Of
course, definitive evidence of efficacy is not an expectation or a requirement
of Stage I.  However, when proposing a Stage II study, investigators are
encouraged to provide evidence that the new therapy shows promise in some way
(such as in terms of a reduction in drug use, dropout rate, or psychiatric
symptoms).  If evidence of promise does not exist, or such evidence is not
strong enough to warrant progression to Stage II, applicants are encouraged to
reconsider a Stage II submission.  That is, they are encouraged to consider
either ceasing the therapy development work or submitting another Stage I
application that addresses issues raised in the prior Stage I project.
Investigators who believe that significant modification of the therapy is
needed before it can be tested in another population are referred to the
section of this PA entitled, "Stage I Research."

As in Stage I, in Stage II research designs are determined by the research
questions.  In general, Stage II research asks if a therapy is efficacious,
but also asks for whom is the therapy efficacious, and under what conditions
and in what amount.  The most common research design for Stage II research is
the randomized, controlled clinical trial.  However, there may be
circumstances in which other types of research designs may be appropriate and
scientifically justifiable.  Knowing the effective components of a therapy can
greatly aid in improving the quality of that therapy.  Research designs used
to determine the effective components or combination of components in drug
dependence behavioral therapies are encouraged.  It is recognized that for
many research questions asked in the behavioral therapy field, no perfect
research design may exist.  Where there is more than one way to answer a
proposed research question, investigators are urged to state their
theoretical, ethical, and practical reasons for choosing one control group or
one research design over another.

Progression to Stage III may occur when a behavioral therapy has been proven
to be efficacious.  It should also be noted that information gathered in Stage
II (or in Stage III) may lead an investigator back to Stage I.  For example, a
therapy is shown to be efficacious for a substantial majority of the
population, but for some individuals it is ineffective, and the investigator
believes he or she can develop a new therapy for these individuals, based upon
information gathered in the Stage II study.

Stage III Research.  Where a behavioral therapy has been shown to be
efficacious in Stage II research, investigators may propose to carry out a
study to address the therapy's transportability to a community treatment
setting.  Stage III research addresses not only if a therapy can be
transported, but also how and for whom a therapy may be transported to the
community.  Thus, Stage III research may address issues of generalizability to
different settings and patient populations more broadly representative of
those in the community.  Such research may test the acceptability of the
therapy to patients, counselors, and therapists in the community.  Thus, it
may involve research on the refinement or modification of the therapy, as
appropriate.  Stage III research may also address questions about the amount
or dosage of therapy required.

One of many potential Stage III research paradigms is a randomized clinical
trial conducted in a community setting.  However, it is important to note that
such a randomized clinical trial cannot be conducted adequately unless
therapists are trained to competently administer the therapy.  This raises yet
another research question.  That is, the question of how to train previously
trained therapists and counselors to effectively utilize new therapies. 
Hence, Stage III also consists of a new research area: research on the
training of therapists.  This includes research on the development of
procedures and techniques to train therapists to administer new therapies. 
Conceptually, such research is analogous to a Stage I research, in the sense
that a new behavioral intervention is under development.  In this case,
however, the new behavioral intervention is not a behavioral therapy, but a
procedure or technique to help therapists to administer new therapies.  The
investigator might, for example, develop the training procedure, pilot the
procedure in the community clinic, refine the procedure, and ultimately test
the training procedure in comparison with another training procedure and/or a
"training as usual" condition (analogous to Stage II).

HIV Considerations.  It should be noted that if a subject is identified as
being at risk for HIV acquisition and/or transmission, HIV testing and
counseling should be offered to the subject in accordance with current
guidelines.  Wherever appropriate, investigators are encouraged to collect
data on the effect of their behavioral therapy on AIDS risk behaviors,
including data on the route of drug administration and sexual behaviors that
may place individuals at risk for HIV transmission.  Also, where appropriate,
investigators are encouraged to offer risk-reduction counseling and to collect
data on the effect of their therapy on the acquisition/transmission of other
infectious disease associated with drug use.


It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).  All investigators proposing research
involving human subjects should read the "NIH Guidelines for Inclusion of
Women and Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and
reprinted the NIH Guide for Grants and Contracts, Vol. 3, No. 11, March 18,


It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines on the Inclusion of
Children as Participants in Research Involving Human  Subjects" that was
published in the NIH Guide for Grants and Contracts, March 6, 1998, and  is
available at the following URL address:


The National Advisory Council on Drug Abuse recognizes the importance of
research involving the administration of drugs to human subjects and has
developed guidelines relevant to such research.  Potential applicants are
encouraged to obtain and review these recommendations before submitting an
application that will administer compounds to human subjects.  The guidelines
are available on NIDA's Home Page at under What's New
or may be obtained by calling (301) 443-2755.


Applications are to be submitted on grant application form PHS 398 (rev.
4/98).  Application kits are available at most institutional offices of
sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources,  National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Phone (301) 435-0714,

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

BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)


These instructions apply to applications requesting up to $250,000 direct cost
per year.

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities
and Administrative (F&A) costs] for the initial budget period.  Items 8a and
8b should be completed indicating the Direct and Total Costs for the entire
proposed period of support.

of the PHS 398.  It is not required and will not be accepted with the

categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See for sample pages.) 
At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000.  List the individuals/ organizations with whom consortium or
contractual arrangements have been made, the percent effort of key personnel,
and the role on the project.  The total cost for a  consortium/contractual
arrangement is included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team.  A biographical sketch is required for
all key personnel, following the instructions below.  No more than three pages
may be used for each person.  A sample biographical sketch may be viewed at:

- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.

o  CHECKLIST - This page should be completed and submitted with the
application.  If the F&A rate agreement has been established, indicate the
type of agreement and the date. It is important to identify all exclusions
that were used in the calculation of the F&A costs for the initial budget
period and all future budget years.

Applications requesting up to $250,000 direct cost per year and not conforming
to these guidelines will be considered unresponsive to this PA and will be
returned without further review.


Applications that are complete will be evaluated for scientific and technical
merit to an appropriate peer review group convened in accordance with the
standard peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed, assigned a
priority score, and receive a second level of review by the appropriate
national advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding  of
biological systems, improve the control of disease, and enhance health.  In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

(1)  Significance:  Does this study address an important problem?  If  the
aims of the application are achieved, how will scientific knowledge be
advanced?  What will be the effect of these studies on the concepts or methods
that drive this field?

(2)  Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3)  Innovation:  Does the project employ novel concepts, approaches or
method? Are the aims original and innovative?  Does the project challenge
existing paradigms or develop new methodologies or technologies?

(4)  Investigator:  Is the investigator appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?

(5)  Environment:  Does the scientific environment in which the work will be
done contribute to the probability of success?  Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements?  Is there evidence of institutional

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities, and their
subgroups as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research

o  The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.


Applications will compete for available funds with all other approved
applications assigned to that Institute/Center/Division.  At NIDA, special
consideration will be given to applications that directly deal with
AIDS-related issues.  The following will be considered when making funding
decisions:  scientific and technical merit of the proposed project as
determined by peer review; availability of funds; and Institute/Center program
needs and balance.


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:

Lisa S. Onken, Ph.D.
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4229, MSC 9563
Bethesda, MD 20892-9563
Telephone:  (301) 443-0107

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9451
Telephone:  (301) 443-6710

Direct inquiries regarding review to:

Teresa Levitin, Ph.D.
Director, Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755


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
(42 USC 241 and 290cc) and administered under PHS grants policies and Federal
Regulations at Title 42 CFR Part 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.  Awards must be administered in accordance with the PHS Grants Policy
Statement, (Rev., 4/94), which may be available from the institutional office
of sponsored research.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

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