Director's Report to the National Advisory Council on Drug Abuse
New Program Announcements/RFAs
A new prevention research announcement, "Drug Abuse Prevention Through Family Intervention," was issued by NIDA on January 26, 1996. The purpose of the announcement is to test under controlled conditions, the efficacy and effectiveness of theory-based drug abuse prevention intervention for families at risk for abusing drugs.
The Clinical Medicine Branch, Division of Clinical and Services Research has issued a program announcement, Medical and Health Consequences of Drug Abuse (PA 96-010), that appeared in the NIH Guide, Vol 24, No.24, December 8, 1995. The purpose of this PA is to stimulate a wide range of studies on the medical and health consequences of drug abuse, including mental disorders. The announcement encourages research on factors, processes and mechanisms associated with the onset, duration, clinical manifestations and treatment of medical and health consequences of drug abuse. This includes general population-based and clinical epidemiologic, clinical, and laboratory studies which address issues of morbidity and mortality of drug abuse.
In December 1995, MDD published RFA 96-03 "Novel Pharmacotherapies for Cocaine and Other Psychostimulant Dependence". Interest to date appears quite high. The application deadline is February 21, 1996 and of January 24, 25 letters of intent had been received. This RFA specifically excludes mechanisms associated with the Biogenic Amine Transporter.
On January 26, 1996, NIDA, together with the National Institute of Justice, the NIH Office of Behavioral and Social Sciences Research, the NIH Office of Research on Women's Health, The National Institute on Aging, The National Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, the NIH National Center on Child Abuse and Neglect and the Centers for Disease Control and Prevention issued an RFA (OD-96-002) entitled "Research on Violence Against Women and Violence Within the Family".
Medications Development Research Units (MDRUs)
The Medications Development Division, in cooperation with the Department of Veterans Affairs, completed the site review and competitive selection process for clinical Medication Development Research Units (MDRUs) to be located within the VA system. Specifically, the MDRUs will evaluate compounds that treat the symptoms and disease of drug abuse, including medications to: achieve abstinence; block the effects of abused drugs; reduce the craving for abused drugs; block or reverse the toxic effects of abused drugs; and prevent relapse in persons who have been detoxified from drugs of abuse.
In response to a request for proposals released last December, 26 proposals were received, 19 proposals were peer reviewed, seven medical centers were site visited and five were selected for funding. The network of MDRUs will be established at the following VA Medical Centers: Boston (Domenic A. Ciraulo, M.D.): Cincinnati( Eugene Somoza, M.D., Ph.D.); New York/Northport (John Rotrosen, M.D.) Philadelphia (Charles O'Brien, M.D., Ph.D.) and West Los Angeles (Walter Ling, M.D.). Each unit provides a unique combination of staff with expertise in addiction medicine and the medications development process and well established affiliations with private and public sector institutions.
In April 1995, a presentation was made to the FDA Drug Abuse Advisory Council (DAAC) leading to DAAC recommendation of approvability of buprenorphine mono substance for drug abuse treatment. Specific pharmacokinetic studies are still required by the FDA prior to filing of the buprenorphine and buprenorphine/naloxone combination NDAs. It is the sponsor's intention to launch the mono with the combo in 97; final NDA for mono is targeted for submission on 6/96. Buprenorphine mono substance has been successfully registered for treatment of opiate dependence in France with product launch in October 1995, based in considerable part on U.S. experience and data.
Health Services Research Centers
Two new health services research center grants were funded in September: the Center for Research on Substance Abuse Managed Care, at Brandeis University (Dennis McCarty, Ph.D., Center Director) and the Center for Health Services Research on Chronic Drug Users, at the University of Miami (Clyde McCoy, Ph.D., Center Director).
Health Services Research Resource Center
Under NIDA's Health Services Research Resource Center contract several tasks are under way including:
- completion of a compendium of research-based talking points on treatment effectiveness;
- an extensive annotated bibliography on treatment effectiveness;
- the development of a literature review on prevention and treatment assessment methodologies; and
- an upcoming developmental meeting on information systems management for the Center.
Women's Health Supplements
The NIH Office of Research on Women's Health, through their annual supplement program, awarded 4 administrative supplements to current NIDA grants. This supplement program stimulates current NIH grantees to address women and gender issues. For the first year, NIDA has funded some of the applications ORWH was unable to fund. Of the 20 applications NIDA submitted to ORWH for possible funding, NIDA funded 11. The 20 applications represented approximately one fourth of those submitted by NIDA grantees. All applications submitted to ORWH by NIH institutes were reviewed by a DRG-conducted committee of NIH program staff. Drs. Jag Khalsa (Clinical Medicine Branch, DCSR) and Cora Lee Wetherington (Behavioral Pharmacology Branch, DBR & Women's Health Coordinator) served on the review committee.
Minority Health Supplements
The NIH Office for Research on Minority Health provided supplemental funds to grantees to support several minority program efforts proposed by NIDA. These include a Native American initiative which focuses on efforts to design effective drug and HIV/AIDS prevention programs with Native American populations and meetings to promote research collaborations between majority and minority institutions, stimulate the involvement of community-based organizations in drug abuse research in African American and Hispanic communities, and better understand drug abuse research career development patterns and needs in African American populations.
NIDA Abuse Liability Review Committee
In response to a request from the NIDA Advisory Council (February 1995), a NIDA-wide Abuse Liability Review Committee has been formed. Dr. Lynda Erinoff (BSRB/DBR) is committee coordinator, and the committee is reporting to NIDA's Deputy Director,
Mr. Richard Millstein. The committee held its first meeting in November and decided to frame its efforts by addressing several broad questions: What is the current extramural and intramural portfolio in abuse liability research and testing? What is the current scientific basis for abuse liability testing? What gaps/opportunities exist? How can communication of abuse liability issues within NIDA and dissemination of results to the outside world be improved? Dr. Art Jacobsen will address the Committee at its next meeting.
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