Full Text DA-97-001 CRAVING IN DRUG ABUSE AND ADDICTION NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA: DA-97-001 P.T. 34 Keywords: Addiction Drugs/Drug Abuse National Institute on Drug Abuse Letter of Intent Receipt Date: June 24, 1996 Application Receipt Date: July 24, 1996 PURPOSE The National Institute on Drug Abuse (NIDA) is seeking research applications to study the nature, determinants, and consequences of drug craving as well as potential interventions on drug craving. The objective of this Request for Applications (RFA) is to encourage the investigation of craving to further our understanding of and treatment for drug abuse and addiction. 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, Craving In Drug Abuse and Addiction, 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 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 First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01), FIRST Award (R29), exploratory/developmental grant (R21), and small grant (R03). Competing continuation applications of ongoing grants are excluded from this solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The anticipated award date is March 1, 1997. Awards made under the R29, R03 or R21 mechanism may not be renewed, but it is expected that projects supported by these mechanisms will provide sufficient data to apply for support of a research project grant (R01). There are special requirements and criteria for the FIRST (R29) award and small grant (R03) grant applications. If any applicant intends to apply utilizing any of these mechanisms, he or she should contact the program person listed in INQUIRIES for further information. FUNDS AVAILABLE It is anticipated that up to $2 million in FY 1997 will be available to support projects submitted under this RFA. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will vary also. However, it is anticipated that approximately six to seven new awards will be made under this RFA. RESEARCH OBJECTIVES Many scientists and treatment providers in the field of drug abuse believe that craving plays a critical role in the maintenance of and relapse to drug abuse. Accordingly, a number of definitions and theoretical models including cognitive, neuronal, behavioral, social, and motivational factors have been proposed to delineate the processes involved in craving. While some models have attempted to confirm suggested relationships between drug craving, drug seeking behavior and relapse, others have focused on subjective factors such as potential distinctions between craving and liking (i.e., craving can occur in the absence of liking), or between craving and urges. Still other models have placed wants, desires, urges and cravings along a continuum of increasing intensity. Although there is support for the idea that craving is an important subjective motivational state, the empirical relationships between craving and physiological measures or drug seeking behavior have not always been straightforward. For example, self-reports of craving in human subjects frequently do not correlate with physiological measurements or actual drug taking. Because at present there is no consensus on how best to elucidate the nature of drug craving, NIDA is encouraging rigorously designed and controlled research to increase our knowledge and understanding of craving, and the relationship between craving, drug abuse and addiction. A wide range of research in both existing and new frameworks is encouraged. Both animal and human research and multidisciplinary approaches are encouraged. Gender differences or gender-specific effects on craving (e.g., effects of menstrual cycle) are also of interest. Additionally, because craving has been a major focus of study in ingestive behaviors and eating disorders research as well as in alcoholism research, applications that relate these models and hypotheses to issues in drug abuse are encouraged. Examples of research topics responsive to this RFA solicitation may include, but are not restricted to, the following: o Elucidate the role of learning, memory, and perceptual processes in drug craving, withdrawal, and relapse. o Characterize craving as a function of drug type, duration, frequency and pattern of drug use (e.g., chipping, binging) and route of administration. o Elucidate how differing demographic, genetic/familial, ethnic or individual variations influence craving, and how such differences are manifested at differing stages of the lifespan. o Determine the relationship between brain reward systems, neurotransmitter systems and drug craving with use of a variety of methods including neuroimaging. o Identify the behavioral mechanisms (e.g., cognitive, associative, motivational, reinforcement) underlying craving. o Experimentally differentiate the subjective states of needs, urges, wanting, liking, craving, and withdrawal or other as yet uncharacterized experiential states. o Compare craving for drugs with craving for other substances or physiological outcomes. Examine interactions of drug craving with feeding behavior. o Develop animal models of new pharmacological and non- pharmacological treatments of craving and relapse. In particular, animal models of relapse are needed that relate to drug use patterns in humans. o Study personal narratives of craving to identify common characteristics of the quitting/abstinence and/or relapse experience. o Investigate the utility of tailoring treatment approaches for drug craving, including behavioral or pharmacotherapies, based on the type of drug that is used or craved. o Characterize the association between craving and other psychiatric symptoms and conduct disorders and (e.g., obsessive compulsive spectrum disorders, gambling, depression, anxiety, psychoses) that can co-occur with drug abuse and/or addiction. o Develop, improve and validate methods and instruments for measuring craving, including individuals seen in a variety of treatment settings including primary care settings. 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 June 24, 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 may be 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 also will allow program staff to assess the responsiveness of the potential application to this RFA. Consequently, prior to submitting a letter of intent, applicants are strongly urged to contact program staff. The letter of intent is to be sent to: Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the application form PHS 398 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 2 on the face page of the application form and the YES box must be marked. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact 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 service) 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 Applications must be received by July 24, 1996. If an application is received after this date it will be held for the next regular receipt date and reviewed under standard circumstances; however, it will not be considered as a response to this RFA. The Division of Research Grants (DRG) will not accept any application in response to the 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 the DRG and responsiveness by the National Institute on Drug Abuse (NIDA). Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the applicant may be contacted 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 the NIDA in accordance with the NIH peer review criteria 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 review by the NIDA's National Advisory Council. Review Criteria o relevance of the proposed research to the objective of this RFA; o scientific, technical or medical significance and originality of proposed research; 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; and, o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Funding decisions will be made on the basis of overall scientific and technical merit of the proposal as determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human and animal subjects, and availability of funds. In addition, criteria for awards will be based on the Research Objectives listed earlier. Dates for submission, initial review, council and award for this solicitation are shown below: Letter of Intent Receipt Date: June 24, 1996 Application Receipt Date: July 24, 1996 Initial Review Date: September 1996 Advisory Council Date: January 1997 Earliest Start Date: March 1997 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: Dr. Jaylan S. Turkkan (basic research) Telephone: 301-443-1263 FAX: 301-594-6043 Email: jaylan@nih.gov (or) Dr. Jack Blaine (treatment research) Telephone: 301-443-0107 jblaine@aoada.ssw.dhhs.gov at the following address: National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-12 Rockville, MD 20857 Direct inquiries regarding fiscal or grants management issues to: Dr. Gary Fleming, Chief Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: 301-443-6710 Email: GFLEMING@AOADA.SSW.DHHS.GOV AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, 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. The Public Health Service 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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