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Director's Report to the National Advisory Council on Drug Abuse
February, 1995

Program Activities

Historically Black Colleges and Universities Initiative

Under our HBCU initiative, two contracts were awarded in September to Howard University. The first, Drug Abuse Research Technical Assistance Project (DARTAP), awarded to Dr. Ernest Quimby in the Dept. of Sociology is to provide assistance to HBCUs in developing drug abuse researchers and research programs. The second awarded to Dr. William West in the College of Medicine is to establish a drug abuse research center on the campus. Both are three year awards with two option years.

NIH Office of AIDS Research

The Office of AIDS Research, NIH, has begun the planning process for FY1997. NIDA staff are participating in this process to identify programmatic initiatives for 1997 in the areas of etiology and pathogenesis, epidemiology and natural history, behavioral research, vaccine development, and information dissemination.

Using Case-Mix Adjusted Client Outcomes in a Quality Assurance System: The Methadone Treatment Quality Assurance System (MTQAS) Feasibility Study

The Methadone Treatment Quality Assurance System (MTQAS) feasibility study supported by NIDA and being conducted by the Research Triangle Institute, was designed as a performance-based reporting and feedback system for narcotic addiction treatment programs. Its purpose is to develop client outcome information that can be used to improve the quality of treatment services delivered. After a period of client level data collection, each of the 25 clinics participating in the MTQAS project were sent individualized feedback reports that gave them information about client characteristics and rankings on a variety of outcomes. With the increase in numbers and span of managed care organizations, the ability to collect and use outcome data will be crucial to substance abuse treatment agencies.

NIDA/NIAID Collaboration to Conduct WITS II Study

By means of a recent Memorandum of Understanding (MOU), NIDA and the National Institute of Allergy and Infectious Diseases (NIAID) have formalized their collaborative research efforts regarding the impact of HIV infection in pregnant, drug-using women and their offspring. NIDA will provide support for one of the sites (Columbia University) of the NIAID-supported Women and Infants Transmission Study II (WITS II), a multi-center study of factors related to maternal-infant HIV transmission and to disease progression among the women and their infected children. NIDA funds will enable continued development of Columbia as the core site for enhancing research on the drug use related aspects of the WITS II agenda, and will allow for continued follow-up of a cohort of pregnant HIV-infected women, the majority of whom are drug users.

Medications Development Research Centers

Five (5) P50 Medications Development Research Centers were funded in last quarter of 1994. Each award is for 5 years. Awards were made to the following sites: Yale University, The University of Minnesota, The University of Texas at Houston, Columbia University, and the Los Angeles Addiction Treatment Research Center to study cocaine and opiate pharmacotherapies. Approximately 80% of the funds awarded under these grants was identified as dedicated for studying new cocaine therapies.

Contracts for Medicinal Chemistry Design and Synthesis

In September 1994, 6 contract awards were made to provide medicinal chemistry design and synthesis, with the aim of discovering a treatment agent for cocaine abuse, to MDD/NIDA. A total of 121 new compounds have been proposed from the 6 contracts. This program is somewhat unique in that it is a multi-award contract program which requires the offerors to provide 1 gram quantities of compounds and to work in certain R&D areas of medicinal chemistry development of specific interest to the Medications Development Division. However, once they have satisfied the direct requests of MDD, they are free to propose and pursue a range of structural approaches of their own choosing. This makes the program somewhat of a hybrid of the contract and grant mechanisms. The response to this solicitation was unusually large (11 received, 6 funded) and the productivity has been exceptionally high in terms of numbers of compounds received.

Biostatistical Support Center

A biostatistical support center has been established at Palo Alto VA/Stanford University under direction of Philip Lavori. The center will provide statistical consultation for NIDA VA sites, review data provided to MDD from clinical trials, and analyze and report safety and efficacy data to NIDA's Data Safety Monitoring Board.

Outpatient Study of Selegilene

An out-patient study of selegilene to reduce cocaine use has been reviewed/approved, an IND obtained, and the study begun under clinical trial agreement with Pharmavene, Inc. Four sites are participating (DCVA, Brentwood VA, Philadelphia VA, and UCSF). To date, 20 patients have been enrolled (expected to recruit 140 patients). No adverse events have been reported to date.

New Program Announcements/RFAs

On November 18, 1994, a program announcement (PA-95-005) was released on "AIDS, Drug Abuse and Neurobiology." The purpose of this program announcement is to enhance knowledge regarding drug modulation of the HIV infectivity and progression to AIDS by understanding how drug abuse affects HIV-related disease states.

The Program Announcement (PA 95-008) entitled "Innovative Methods for Screening Drugs to Treat Cocaine and Opiate Abuse" was published in the NIH Guide on November 25, 1994. The purpose of this 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 opiate 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 opiate abuse and their pharmacologic treatment. These methods should be novel or they should significantly expand other undeveloped or unrecognized methods or models as tools for evaluating pharmacotherapies for drug abuse disorders.

On January 20, 1995, NIDA released a program announcement (PA 95-022) soliciting proposals for "Drug Abuse Health Services Research and HIV/AIDS" which will support a program of research on health services to drug abusers at high risk for HIV/AIDS at the client, program and service system level.

An addendum to the Behavioral Therapies Development Program Announcement (PA 94-078) was issued to encourage the incorporation of HIV risk reduction strategies as an integral component in the development of behavioral therapies for drug abuse and dependence treatment and to encourage the use of HIV risk measures and the provision of HIV testing and counseling to participating subjects.

NIDA, in conjunction with 7 other NIH Institutes issued a program announcement on "Basic and Clinical Research on Sleep and Wakefulness" (PA-95-014) on December 23, 1994 to stimulate, foster, and coordinate a wide range of basic and clinical studies on sleep and wakefulness as they relate to the missions of these Institutes.

On February 3, 1995, a program announcement entitled "HIV Disease Progression in Drug Users" was published in the NIH Guide. The purpose of this announcement is to stimulate research on the biological and behavioral factors influencing HIV disease progression in populations of drug users both in- and out-of drug abuse treatment, in order to facilitate prevention and treatment efforts. An RFA on "Neuroscience Networks in Basic Drug Abuse Research" (DA-95-001) was published on January 13, 1993. This initiative is intended to stimulate novel insights and innovative approaches in drug abuse research through the establishment of national, collaborative networks of investigators active in the neurosciences; to encourage and enable neuroscientists not currently focused on drug abuse research to explore applications of their expertise to the field; and to develop experimental prototypes of research enterprises which exploit emerging communication and information technologies to form "virtual research centers" in the drug abuse field.

An RFA entitled "Human Basic and Clinical Neuroscience of Drug Addiction" was published on February 3, 1995. This announcement is intended to stimulate research using noninvasive technologies to study the human brain and the etiology and consequences of drug abuse and to translate this information into novel prevention, diagnostic, and treatment strategies.

NIDA HIV/AIDS Counseling and Testing Policy.

The policy, which will require grantees and contractors to provide HIV preventive services, is in the final stages of Institute review.

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