Full Text PA-95-008 INNOVATIVE METHODS FOR SCREENING DRUGS TO TREAT COCAINE AND OPIATE ABUSE NIH GUIDE, Volume 23, Number 41, November 25, 1994 PA NUMBER: PA-95-008 P.T. Keywords: National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to encourage research to develop innovative preclinical methods and model systems (for example, in rodents or non-human primates) for the identification of potential treatment agents for the entire spectrum of cocaine and opioid abuse, from pre-addiction through abstinence, relapse, and recovery. The methods may be based upon behavioral, neurophysiologic, neurochemical, or other approaches as long as a strong case is made that they will be relevant to human cocaine and opioid abuse and their pharmacologic treatment. These methods should be novel or they should significantly expand other undeveloped or unrecognized methods and models as tools for evaluating pharmacotherapies for drug abuse disorders. 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 program announcement, Innovative Methods for Screening Drugs to Treat Cocaine and Opiate Abuse, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. 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 and small grants (R03). MECHANISM OF SUPPORT The mechanisms available for support of this program announcement are the regular research project grant (R01), the small grant award (R03), and the FIRST award (R29). Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Several behavioral models of drug abuse have been useful in studying important variables in the laboratory. Perhaps the most widely recognized of these is the self-administration model in which an animal presses a lever to inject an abused drug intravenously. This methodology has been an invaluable research tool in many ways, especially in the preclinical evaluation of the abuse potential of compounds. The drug discrimination model is a second method that has proven useful. In this method, an animal is trained, on the basis of internal (interoceptive) cues, to make one response when a particular drug is injected, and to make a different response when a different drug (or placebo) is injected. This procedure has proved valuable in assessing the subjective effects (e.g., the "high") of cocaine or opioids, as well as the likelihood that an unknown compound produces a similar interoceptive cue. The self-administration and discrimination models in rodents and non- human primates do not cover all aspects of human drug abuse and addiction including drug seeking, initiation, maintenance, dose escalation, extinction, relapse, remission, and recovery. Animal models to study the multiple phases of cocaine or opioid abuse have not been well developed or validated. This has hampered the identification and development of new medications that may be useful in treating abuse of these substances. The development of such new animal models promises to represent an important advance regarding identification and development of a wider range of medications that treat cocaine and opioid abuse. At the present time, no validated models exist to represent the human recovery phase following treatment for substance abuse in which the subject strives not to return to previous behaviors, namely drug seeking and drug taking. This lack of suitable animal models restricts the study of variables which contribute to relapse to drug seeking behavior and drug taking. Areas of research interest include those that are innovative, that develop new methods of drug discovery for treatment of cocaine and opioid abuse and that will advance the development of new medications for treatment of abuse of these substances. In general, these may include, but are not limited to: o An innovative behavioral model for craving and/or drug seeking behavior. o Techniques to study behavior after treatment for drug abuse as experimental models of recovery and/or relapse. o Neurophysiologic and/or neurochemical techniques that utilize the underlying mechanisms of cocaine and/or opioid abuse as means to identify new potential pharmacotherapies. These areas of research are not intended to be all-inclusive. However, experimental models to develop therapeutic interventions for cocaine and opioid abuse are extremely limited. Within the area of opioid abuse despite the availability of effective maintenance medications, relapse is still a major issue. Thus, a major research effort is required to design innovative approaches to expand the current methods and models to those that have not been explored. Well-known models of drug abuse to study cocaine and opioid abuse are of interest only insofar as their application constitutes an innovative approach. It is anticipated that no single method will be definitive. It is further anticipated that both behavioral and non- behavioral techniques will be identified and developed. The PHS Policy on Humane Care and Use of Laboratory Animals by Award Institutions requires that applicant organizations establish and maintain appropriate policies and procedures to ensure the humane care and use of live vertebrates involved in research, research training, and biological testing activities supported by the PHS. All institutions are required to comply, as applicable, with the Animal Welfare Act as amended (7 USC 2131 et sec.). These documents are available from the Office for Protection from Research Risks (OPRR), National Institutes of Health, Bethesda, MD 20892. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/435-0714. The title and number of the program announcement must be typed in item 2a of face page of the application. FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies of the PHS 398 form must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by a study section of the Division of Research Grants, NIH (or by the review group of the relevant Institute, Center or Division) in accordance with standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council. As part of the initial merit review, a process (triage) will be used by the initial review group to determine whether an application is competitive or non-competitive based on the scientific merit relative to other applications received in response to the program announcement. Applications judged to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria 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 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; The initial review group will also examine the provisions for the protection of human and animals subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review; availability of funds; program priority, needs and balance. For applications assigned to the NIDA, preference will be given for innovative methods to identify medications for treating cocaine and opioid abuse. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Heinz Sorer, Ph.D. Medications Development Division National Institute on Drug Abuse 5600 Fishers Lane, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-6270 Email: hsorer@aoada.ssw.dhhs.gov Direct inquires regarding fiscal issues to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS 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." 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. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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