Full Text DA-97-002
 
NEUROBIOLOGICAL EFFECTS OF DRUG ABUSE THERAPIES
 
NIH Guide, Volume 25, Number 22, July 5, 1996
 
RFA:  DA-97-002
 
P.T. 34

Keywords: 
  Drugs/Drug Abuse 
  Treatment, Medical+ 
  Nervous System 

 
National Institute on Drug Abuse
 
Letter of Intent Receipt Date:  September 18, 1996
Application Receipt Date:  October 18, 1996
 
PURPOSE
 
This Request for Applications (RFA) solicits research grant
applications on the neurobiological effects of pharmacological and/or
nonpharmacological drug abuse treatments upon structure and/or
function of the human central nervous system.  Results from such
studies should ultimately provide a basis for the development and
improvement of behavioral and medication treatment of patients with
drug abuse disorders.
 
This research program is intended to support individual research
project grants and mentored career development awards on the clinical
neurobiological effects of specific treatments for drug abuse
disorders.  Research using animals is not excluded, but any animal
research in projects submitted under this RFA must serve an
essential, but secondary role, in a predominantly clinical study.
 
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 RFA,
Neurobiological Effects of Drug Abuse Therapies, 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 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic, for-profit and
non-profit 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.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards or career development (K-
series) awards.  Awards to foreign institutions under other
mechanisms are limited to three years.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) research
project grants (R01), exploratory/developmental grant (R21), small
grant (R03), and FIRST Award (R29), as well as Mentored Research
Scientist Development (K01) and Mentored Clinical Scientist
Development (K08) Awards.  Most investigator-initiated research is
supported by research project grants (R01).  The total project period
for an application submitted in response to this RFA may not exceed
five years.  This RFA is a one-time solicitation.  Future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to
customary peer review procedures.  Applications judged to be
non-responsive to the RFA will be held for the next regular receipt
date.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, the size of an award will vary also.
 
The exploratory/developmental (R21) and small grant (R03)
applications are limited to two years, non-renewable, and limited in
direct cost amount per year (R03, $50,000; R21, $90,000)  The R03
mechanism is intended for newer, less experienced investigators,
investigators at institutions without a research tradition and
experienced investigators wishing to change research directions or
test new methods or techniques.  The R21 mechanism is intended to
encourage new research projects in underdeveloped research areas of
drug abuse.  Applicants for the R21 mechanism are expected to be
experienced investigators whose previous research may have been
distantly related areas to drug abuse (e.g., mental health) but whose
expertise is applicable to drug abuse research. Mentored Research
Scientist Development Award (K01) and Mentored Clinical Scientist
Development Award (K08) are both mid-career grants intended to
provide a period of sponsored research experience which will then
enable the applicant to pursue an independent research career.  The
K01 and K08 awards support three to five years of mentored research
experience and applicant are required to devote at least 75 percent
time to the program.  K01 Awards require a research or a
health-professional doctorate or equivalent, while K08 Awards require
a clinical degree or equivalent.  There are additional special
requirements for these mechanisms; if any applicant intends to apply
for them under this RFA, they should contact the program official
listed under the INQUIRIES section for further information.
 
FUNDS AVAILABLE
 
In FY 1997, it is anticipated that approximately ten to twelve awards
may be funded at a total cost of up to $1.5 million.  Approximately
five regular grant (R01) awards at an average of $200,000, and five
to seven awards under the other mechanisms are anticipated.
 
RESEARCH OBJECTIVES
 
Recent advances in clinical neurobiological methods have armed
researchers with a powerful set of approaches to investigate how
drugs of abuse affect the brain.  However, little is known about how
brain function may be influenced by drug abuse treatment.  The
principal goal of the research to be supported through this
initiative is to identify how structure and/or function of neuronal
systems are affected by specific treatments for drug abuse disorders.
Toward this goal, NIDA is particularly interested in proposals that
will utilize brain imaging or other state-of-the-art clinical
neurobiological approaches for assessment of alterations in human
brain function and structure during treatment for drug abuse
disorders.  The following specific research questions serve as a
guide to the types of research areas that are encouraged in this RFA:
 
o  Important relationships between substance abuse disorders and
comorbid neuropsychiatric disorders have been described, but the
mechanisms underlying these interactions and their implications for
drug abuse treatment remain poorly understood.  Investigators are
encouraged to determine the neurobiological mechanisms underlying
these relationships in the drug-abuse treatment situation.
 
o  Concurrent use of multiple drugs of abuse poses a serious and
frequent clinical challenge in drug abuse research and treatment.
NIDA encourages studies aimed at detection and neurobiological
characterization of differences in treatment response between single-
and polydrug abusers.
 
o  Both pharmacological and behavioral treatment modalities have been
shown to be effective, and clinically significant interactions
between these modalities have been demonstrated.  Very little is
known, however, about the mechanisms underlying these interactions.
Therefore, studies characterizing the mechanistic commonalities and
differences between these treatment modalities are encouraged, as are
studies that elucidate the neurobiological basis of interactions
between combined treatments.
 
o  Similarly, studies that will detect and characterize
neurobiological markers predictive of treatment efficacy are also of
interest.
 
o  Recent research has demonstrated that gender differences may vary
depending upon the combination of drugs of abuse.  Further studies
assessing gender differences in neurobiological response to treatment
are strongly encouraged.  Also, studies assessing ethnicity or
HIV/AIDS status-differences in neurobiological effects of treatment
are particularly welcome.
 
All applications must address issues of project feasibility,
implementation of the study, study design, sampling procedure,
instrumentation and measurement, data collection, tracking of
subjects, follow-up, and data analysis, as appropriate.
 
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.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
 
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
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.  Investigators also may obtain copies of the policy
from the program staff listed under INQUIRIES.  Program staff may
also provide additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by September 18, 1996, 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 is being submitted.  Although a letter of
intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains
allows NIDA staff to estimate the potential review workload and 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
Parklawn Building, Room 10-42
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-2620
FAX:  (301) 443-0538
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Grants
Information Office, Office of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, Room
3034, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email: asknih@odrockm1.od.nih.gov.
 
The FIRST (R29) 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 RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label 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 on
line 2a of the face page of the application form and the YES box must
be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight mail service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Director, Office of Extramural Program Review
National Institute on Drug Abuse
Parklawn Building, Room 10-42
5600 Fishers Lane
Rockville, MD  20857
 
Applications must be received by October 18, 1996.  If an application
is received after that date, it will be returned to the applicant
without review. The Division of Research Grants (DRG) will not accept
any application in response to this RFA that is essentially the same
as one currently pending initial review, unless the applicant
withdraws the pending application.  The DRG will not accept any
application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and for responsiveness by the NIDA staff.  Incomplete and/or non-
responsive applications will be returned to the applicant without
further consideration.  Applications that are complete and responsive
to the RFA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the NIDA in accordance with
NIH 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 by
the National Advisory Council on Drug Abuse.
 
Review Criteria
 
o  scientific technical merit and clinical significance and
originality of proposed research;
 
o  relevance to the goals and objectives of this RFA;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  adequacy of plans to include both genders and 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.
 
The initial review group will also examine the provisions for the
protection of human or animal subjects and the safety of the research
environment.
 
The above criteria apply to R01 applications and there are separate
criteria for other mechanisms.  When applying under other mechanisms,
the applicants should obtain a copy of the relevant announcement from
either their office of sponsored research (if located in a
university) or from Grants Management Branch at NIDA (301-443-6710).
These announcements contain instructions for the preparation of grant
applications that must be strictly adhered to and describe review
criteria that would be used by a peer review committee in evaluating
submitted applications.  In addition to the above mentioned criteria,
relevance of the application to the goal and objectives of this RFA
will also be an important consideration.
 
AWARD CRITERIA
 
Award criteria that will be used to make award decisions include:
scientific merit as determined by peer review, availability of funds,
and programmatic priorities.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Arthur MacNeill Horton, Jr., Ed.D.
Division of Clinical and Services Research
National Institute on Drug Abuse
Parklawn Building, Room Number 10A-46
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4877
FAX:  (301) 443-2317
Email:  ah61x@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
Parklawn Building, Room Number 8A-54
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  gf6s@nih.gov
 
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 Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.
 
The PHS strongly encourages all grant 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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