Release Date:  January 25, 2001

RFA:  RFA-DA-01-014

National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 19, 2001
Application Receipt Date:       April 17, 2001



The National Institute on Drug Abuse (NIDA) announces the availability of 
funds to support research on the drug gamma-hydroxybutyrate (GHB) and its 
precursors, gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD).  This 
request for applications (RFA) is being issued in response to the recent 
emergence of GHB, GBL, and 1,4-BD as public health concerns.  Abuse of GHB is 
a novel phenomenon, whose future impact on society is uncertain.  NIDA intends 
to support a broad range of scientific research that is expected to lead to a 
reduction in the abuse of these sedative-hypnotic "club drugs", and to the 
development of treatments for GHB abuse.  

An RFA, "Responding to Club Drugs and Other Emerging and Current Drug Abuse 
Trends," DA-01-010, has been issued concurrently with this RFA.  Applicants 
whose research interests appear to be suited to both DA-01-010 and the present 
RFA may wish to contact NIDA program staff listed under INQUIRIES.


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This RFA, Research On GHB and its 
Precursors, is related to one or more of the priority areas.  Potential 
applicants may obtain a copy of "Healthy People 2010" at


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 and local governments, and eligible 
agencies of the federal government.  Foreign institutions are not eligible for 
R03 grants.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.


This RFA will use the National Institutes of Health (NIH) traditional research 
project (R01), small grant (R03), and exploratory/developmental grant (R21) 
award mechanisms.  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.  Future unsolicited competing continuation applications 
will compete with all investigator-initiated applications and be reviewed 
according to the customary peer review procedures.  The anticipated award date 
is September 30, 2001. 

Support may be requested for a period of up to five years for R01 grant; two 
years for R03 grant 
and three years for R21 grant 


NIDA intends to commit approximately $2,000,000 in FY 2001 to fund 6 to 10 new 
and/or competitive continuation grants in response to this RFA.  Because the 
nature and scope of the research proposed may vary, it is anticipated that the 
size of each award will also vary.  Although the financial plan of NIDA 
provides support for this program, awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number of 
meritorious applications. 



GHB abuse is a recent phenomenon with uncertain medical, behavioral, and 
social outcomes.  GHB is also associated with novel production and drug 
trafficking and distribution systems.  GBL and 1,4-BD are industrial solvents, 
and like other abused solvents, their supply is difficult to control.  Because 
of this difficulty, the need for effective demand reduction approaches is 
great.  GHB and its precursors were legally available to consumers for many 
years in the U.S. as dietary supplement products, but recently GHB was 
scheduled under the Controlled Substances Act, and GBL became a List I 
chemical.  1,4-BD is not scheduled under federal guidelines; however, the Food 
and Drug Administration (FDA) has declared 1,4-BD a Class I Health Hazard.  

GHB has a distinct neuropharmacology, a specific receptor, unique metabolic 
and regulatory relationships to major neurotransmitters in the central nervous 
system (CNS), and unique discriminative stimulus effects.  While GHB is 
naturally present in the brain, and appears to have vital physiological roles, 
the ingestion of GHB can readily achieve concentrations in the brain several 
orders of magnitude greater than normal.  Both 1,4-BD and GBL are readily 
metabolized to GHB; therefore, the term "GHB" is used in most instances in 
this RFA to encompass all three related substances.  When GHB or its 
precursors are abused, the resulting high concentrations of GHB obtained in 
the brain impact on brain systems not normally involved in GHB physiology, and 
may result in adverse acute (e.g., coma, aspiration pneumonia, death) and 
chronic (e.g., tolerance, addiction, severe withdrawal) consequences.  
Moreover, given the recent changes in the availability of lactone solvents, it 
is not known what contaminants are present in illicit sources of GHB.  
Improved prevention and treatment of GHB abuse will result from a better 
understanding of normal GHB system physiology, biochemistry, and ontogeny; 
analytic methods to assess GHB in the body; GHB (and precursor) pharmacology 
and toxicology; epidemiological patterns and trends of GHB abuse; 
vulnerability and resiliency factors for GHB abuse; and long-term 
neurobiological, behavioral, and medical consequences of GHB abuse.  

Cross-disciplinary and multi-disciplinary approaches are encouraged in 
responding to this RFA (e.g., ethnographic approaches; epidemiological 
investigations; genetic, pharmacological, behavioral, and neurobiological 
studies), as are collaborative research endeavors between basic and clinical 
investigators.  NIDA invites researchers to consider a broad range of 
scientific studies using human subjects and preclinical models in the basic 
science, prevention, and treatment of GHB abuse, as illustrated in the 
examples listed below.  In all these examples, researchers are encouraged to 
incorporate a gender analysis in their research design.  Studies within a 
developmental context are of particular interest, since most GHB abusers are 
young.  Moreover, a pharmacological antagonist of the GHB receptor, NCS-382 
(6,7,8,9-tetrahydro-5-[H]benzocycloheptene-5-ol-4-ylidene acetic acid), is 
available through NIDA’s Drug Supply Program and may be particularly useful in 
pharmacological studies.  

GHB and its precursors may have specific, legitimate medical uses in selected 
patient populations; e.g., for the treatment of narcolepsy.  Research 
involving therapeutic applications or putative therapeutic applications of GHB 
or related substances is not within the scope of this RFA.  Research related 
to the possible utility of using GHB or related substances in the treatment of 
drug dependence on other substances (e.g., opiates, alcohol) is not within the 
scope of this RFA.  

Research Areas

In particular, research is needed in the following areas:

o  abuse liability, reinforcing properties, and subjective effects; 

o  long-term consequences (e.g., tolerance, dependence, withdrawal);

o  patterns of abuse and population trends; 

o  effects of Internet marketing and distribution on abuse;

o  basic pharmacology and physiology of GHB;

o  overdose and toxicity; and

o  prevention and treatment strategies.

The research gaps and issues outlined below are examples suggested to assist 
investigators in research on the problems and consequences of GHB abuse.  
Researchers are invited to address other issues and problems associated with 
GHB abuse that are not specifically outlined in the examples below.  

Epidemiological Studies

o  Characterize trends in GHB abuse by geographic area and according to 
demographic and other subpopulation variables (e.g., use by bodybuilders, use 
at raves or circuit parties).

o  Identify subpopulations of GHB abusers, their reasons for use, and 
associated patterns of use, including combination with other abused 
substances, and adverse consequences.

o  Identify the individual and environmental factors associated with 
vulnerability to begin and continue GHB abuse and to experience the adverse 
consequences of abuse.

o  Determine the roles of social networks and group dynamics in leading to 
diffusion of use and in maintaining long-term use;.

o  Determine the role for GHB withdrawal symptoms in continued GHB abuse.

o  Measure vulnerability, protective, and resiliency factors for GHB abuse and 
addiction at the individual, situational, and community levels.

o  Describe the health, behavioral, and social consequences of GHB abuse.

o  Determine the extent and basis of public perceptions and knowledge of GHB.

o  Characterize the role and influence of the Internet on patterns and trends 
of GHB production, marketing, distribution, and abuse.

o  Perform research to evaluate the impact of the recent FDA scheduling on GHB 
abuse and illicit drug choice.

Preclinical Studies

o  Examine GHB’s pharmacological mechanisms, toxicology, pharmacokinetics, and 
interactions with ethanol and other drugs.

o  Characterize the normal biochemistry, molecular and cell biology, 
physiology, and function of endogenous GHB systems, and their pathophysiology, 
as may relate to GHB abuse.

o  Develop animal models to study motivational processes, environmental 
influences, and genetic factors that influence the acquisition and maintenance 
of GHB abuse, and identify associated neural substrates.

o  Identify consequences of acute and chronic GHB administration on 
sensory/perceptual, behavioral and cognitive processes.

o  Characterize GHB tolerance, dependence, and relapse, and study the 
mechanisms and dynamics underlying these phenomena.

o  Determine if acute or long-term administration of GHB induces 

o  Examine possible ontogenetic consequences of GHB exposure, and characterize 
effects of GHB at various stages of development.

o  Identify relative reinforcing and subjective properties of GHB in 
comparison with other, better-characterized, drugs of abuse, using self-
administration and other animal behavioral models.

o  Examine the mechanisms underlying the GHB withdrawal syndrome, including 
the study of potential treatments to ameliorate this withdrawal syndrome and 
determine if the precursors of GHB induce a different withdrawal syndrome.

o  Determine the effects of contaminants present in illicit sources of GHB.

Clinical Investigations

o  Characterize the relative subjective, affective, cognitive and performance 
effects of acute GHB in human subjects.

o  Examine how GHB abuse affects choices to engage in high-risk behaviors 
(e.g., sexual risk taking, HIV exposure).

o  Examine tolerance, dependence and withdrawal and identify strategies for 
the management of withdrawal syndromes in clinical populations.

o  Explore both behavioral and pharmacological approaches to treating GHB 
addiction, or addiction with GHB-polydrug combinations, and the consequences 
of addiction.

o  Develop and improve methods for diagnosing, treating, and increasing 
physician awareness of GHB overdose and poisoning, including research aimed at 
developing and improving rapid analyses for GHB that can be used in medical 
emergency care settings.

o  Develop and improve assays for detecting previous exposure to GHB that 
might be useful following GHB-facilitated assault.

o  Examine pharmacokinetics and characterize pharmacological actions 
(including receptor binding profiles and effects on brain function) of acute 
and chronic GHB in GHB and GHB-polydrug abusers.

o  Determine if there are persistent effects of GHB abuse on cognitive 
processes including learning and memory.

o  Study potential neurotoxic effects using neuroimaging, post-mortem 
investigations, or other approaches.

Prevention Studies

o  Use epidemiological and etiological data to identify potential preventive 
intervention strategies that target GHB abuse (i.e., hypothesis development 

o  Conduct qualitative research to identify strategies communities are using 
to prevent GHB abuse and to assess the efficacy of these approaches.

o  Evaluate the efficacy for preventing GHB abuse of existing drug abuse 
prevention programs designed to target other drugs of abuse.

o  Evaluate universal preventive interventions adapted to target GHB abuse, 
and the unique predictors of GHB abuse, including, for example, brief, 
context-specific interventions delivered in settings where the drug is often 

o  Study selective and indicated interventions targeted at high-risk groups 
(e.g., participants at rave or circuit parties, men who have sex with men, 

o  Assess the impact of policy change on GHB use, including identification of 
the types of policies communities are developing, the impact of policy change 
and policy enforcement on use, and identification of the strategies used to 
implement policy in contexts where GHB is used (e.g., demands placed on clubs 
to ensure a GHB-free environment, club staff training programs).

o  Explore the use of the Internet as a vehicle for innovative dissemination 
of prevention interventions.


It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
a complete copy of the updated Guidelines is available at  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.


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 

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.


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 the recommendations of the Council before 
submitting an application that will administer compounds to human subjects.  
The guidelines are available on NIDA's Home Page at 
under Funding or may be obtained by calling (301) 443-2755.


All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.


Prospective applicants are asked to submit 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 plan the review.

Send the letter of intent (by receipt date listed in the heading of this RFA) 

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier/express service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538


The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge Drive, 
MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email:

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award.  It is anticipated that these changes 
will reduce the administrative burden for the applicants, reviewers, and 
Institute staff.  The research grant application form PHS 398 (rev. 4/98) is 
to be used in applying for these grants, with the modifications noted below.



Modular grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year.  (Applications that request 
more than $250,000 direct costs in any year must follow the traditional PHS 
398 application instructions).  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $250,000) 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 - Prepare 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.  This is not a Form page.

Under Personnel, list all project personnel, including their names, percent of 
effort, and roles on the project.  No individual salary information should be 
provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

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 all personnel, 
and their role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.

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 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 position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects 	  ongoing or completed during the last three years; 
- List selected peer-reviewed publications with full citations.

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.  All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  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 2 of the face page of the application form, and the YES box must be 

The sample RFA label available at has been modified to 
allow for this change.  Please note this is in pdf format.

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

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Research (CSR) 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 
CSR 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.


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDA.  If the application is not responsive to the RFA, 
CSR staff may contact the applicant to determine whether to return the 
application to the applicant or submit it for review in competition with 
unsolicited applications at the next review cycle.

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 
NIDA in accordance with the review criteria stated below.  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 the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the National Advisory Council on Drug Abuse.

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, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 

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.

o  The adequacy of the proposed plan to share data, if appropriate.


Letter of Intent Receipt Date:    March 19, 2001
Application Receipt Date:         April 17, 2001
Peer Review Date:                 June/July 2001
Council Review:                   September 2001
Earliest Anticipated Start Date:  September 30, 2001


Award criteria that will be used to make award decisions include:  scientific 
merit (as determined by peer review), availability of funds, and programmatic 


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Jerry Frankenheim, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 435-1312
FAX:  (301) 594-6043

Direct inquiries regarding review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847


This program is described in the Catalog of Federal Domestic Assistance No. 
93.279.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  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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