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National Institute on Drug Abuse

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

September, 1996


Program Activities


Program Announcements/RFAs



B/START: Behavioral Science Track Awards for Rapid Transition--NIDA

This RFA (Number: RFA 96-005) underscores NIDA's commitment and interest in expanding the scope of basic behavioral sciences research in drug abuse. NIDA invited newly independent investigators to submit applications for small-scale, exploratory (i.e., pilot) research projects related to NIDA's basic behavioral sciences mission. The applications underwent rapid review; the funding status of applications will be determined before the end of the fiscal year. Basic science (mostly laboratory) applications were encouraged in cognitive and perceptual processes, social processes and motivational factors in drug abuse.


Craving in Drug Abuse and Addiction

The objective of this Request for Applications (RFA 97-001) is to encourage the investigation of craving from multiple biobehavioral, clinical, and medications development perspectives to further our understanding of and treatment for drug abuse and addiction. Approximately 40 applications were received in July in response to this announcement.

The Treatment Research Branch, Division of Clinical and Services Research has issued two new addenda to the Behavioral Therapies Development Program Announcement (PA-94 078). The first, which appeared in the NIH Guide (Vol. 25, No. 16) on May 17, 1996, encourages research on the development and testing of assessment instruments and brief behavioral therapies for drug abuse and dependence and related HIV/AIDS risk behaviors for patients that are seen in office-based and other health care settings. The second, published August 9, 1996 (Vol. 25, No. 27), encourages Stage 1 research on the development of new and innovative behavioral interventions for the treatment of drug addicts and the prevention or reduction of HIV risk behaviors in drug abuse treatment populations. The translation of basic behavioral science research into creative new behavioral therapies for drug addicts is the ultimate goal of this addendum.


NIDA's AIDS Program

NIDA's Office on AIDS published an advertisement in the July 28 issue of Science which featured AIDS research and profiled important HIV/AIDS discoveries in recent years. The NIDA advertisement encouraged investigators to undertake research on drug abuse-related aspects of HIV/AIDS.


DC*MADS Data Files and Documentation

Public use data files and documentation for two components of the Washington, D.C. Metropolitan Area Drug Study (DC*MADS) are now available on diskettes from the NTIS. One is for the Study of the Household and Nonhousehold Populations (#PB96-502271GEI) and the second is for the Study of Drug Use and Pregnancy (#PB96-502109GEI). Both can be ordered from NTIS by calling (703) 487-4650.


Small Business Innovation Research Award

NIDA's MDD has awarded a $700,000 Small Business Innovation Research award
to ImmuLogic Pharmaceutical Corporation (Waltham, Massachusetts) to complete preclinical development of a vaccine to treat cocaine dependence. Results of ImmuLogic's early vaccine work in animals has received attention in national and trade press, and was presented at CPDD. The vaccine links a protein to cocaine, resulting in a molecule which induces antibody formulation. Once titers reach a certain level, cocaine's ability to cross the blood brain barrier is diminished. The award will expedite completion of preclinical design and testing of the vaccine with the hope that clinical trials could begin in 1997.


Medications to Prevent Cocaine Dependence Relapse

The Philadelphia VA MDRU has recently screened 6 medications for potential usefulness in preventing relapse to cocaine dependence. One of these, propranolol, seemed so promising in two open studies that a controlled double blind study has recently been instituted.


NIDA/VA Medications Development Research Units (MDRU) Meeting

On June 18-19, the NIDA/VA Medications Development Research Units held their second quarterly meeting in Washington, D.C. June 18 was a general session meeting consisting of a scientific component. The scientific discussions were focused on study design issues and review of cocaine infusion methods. Four NIDA grantees presented data and/or applications of pharmacokinetic/pharmacodynamic cocaine profiles to cocaine infusion methods. Presenters were: Suzette Evans, Ph.D. (Columbia University); George Bigelow, Ph.D. (Johns Hopkins University); Reese Jones, M.D. (UCSF) and Charles O'Brien, M.D., Ph.D. (University of Pennsylvania). On June 19 the subcommittees conducted meetings in the following areas: compound identification; protocol review; pharmacokinetics; design/methods; data management; and psychosocial/behavioral therapies.


Cocaine Clinical Trials Database

The MDD Cocaine Clinical Program has refined the Cocaine Clinical Trials Database and presented the database as a poster at CPDD. The database summarizes data from MDD sponsored clinical trials which have been completed and analyzed.


Multi-Center Protocols at MDRUs

Four clinical multi center protocols at the new Medications Development Research Units (MDRUs, located in Department of Veterans Affairs medical centers) with bupropion, nefazadone, fenfluramine and methylphenidate are in the final stages of revision. All have IRB approvals and patient enrollment is anticipated by October 1, 1996.


Supplements to VA MDRU Studies

Two supplemental studies within the VA MDRU program were approved and funded, one involving human hepatic metabolic pathways to predict potential toxic interaction with medications for cocaine dependence, the other involving PET imaging of dopamine system ligands in cocaine dependent patients.


Multi-Site Trial of Buprenorphine

Paul Fudala, Ph.D. (VA Cooperative Studies Program and University of Pennsylvania) is co-directing with MDD, NIDA (Peter Bridge, M.D.) a multi-site trial of buprenorphine combined with naloxone.


On-Site Reviews of In-Vitro Screening Contracts

MDD utilized expert consultants for on-site reviews of two of its in vitro screening contracts. A contract focusing on the dopamine transporter is located at Oregon Health Sciences University and was visited by Drs. Michael Kuhar, Gary Rudnik, Ken Johnson, Zdenek Pristupa, Deborah Mash, Beth Hoffman, and Maarten Reith. The screening contract at SRI focusses on a variety of other targets and incorporates functional assays to identify compounds as either agonists or antagonists at specific receptor sites. SRI was visited by Drs. Dmitri Grigoriadis, Bob Luedtke, and Richard Mailman.


Structure Activity Relationship (SAR) Committee

On April 5, the MDD Cocaine Treatment Discovery Team formed a Structure Activity Relationship (SAR) Committee in response to the recommendations of expert consultants for an increased role of SAR in drug discovery. The role of the committee is to strategically evaluate compounds in the database to recommend and facilitate rapid testing and to maximize cost-effectiveness of the CTDP testing program. The Committee has focused on classifying all compounds in the data base to evaluate physico-chemical relationships to:
recommend compounds for in vitro testing (BAT)
request from chemists additional synthesis of compounds targeted for further testing.
correlate in vitro results with physico-chemical features
and recommend compounds to proceed to animal testing based correlations.

Incorporate all data into one database and reporting software.

Obtain computer modeling resources for structural and energy relations to biological activity (presently done manually-at best approximation).


Health Services Research Resource Center

NIDA's Health Services Research Resource Center has accomplished several tasks, including the development of annotated bibliographies to support research in the areas of treatment effectiveness, financing, alternative delivery systems, cost-benefit and cost-effectiveness analysis, costs and benefits of treatment, and economics of drug treatment.
NIDA's MDD has awarded a $700,000 Small Business Innovation Research award
to ImmuLogic Pharmaceutical Corporation (Waltham, Massachusetts) to complete preclinical development of a vaccine to treat cocaine dependence. Results of ImmuLogic's early vaccine work in animals has received attention in national and trade press, and was presented at CPDD. The vaccine links a protein to cocaine, resulting in a molecule which induces antibody formulation. Once titers reach a certain level, cocaine's ability to cross the blood brain barrier is diminished. The award will expedite completion of preclinical design and testing of the vaccine with the hope that clinical trials could begin in 1997.


Medications to Prevent Cocaine Dependence Relapse

The Philadelphia VA MDRU has recently screened 6 medications for potential usefulness in preventing relapse to cocaine dependence. One of these, propranolol, seemed so promising in two open studies that a controlled double blind study has recently been instituted.


NIDA/VA Medications Development Research Units (MDRU) Meeting

On June 18-19, the NIDA/VA Medications Development Research Units held their second quarterly meeting in Washington, D.C. June 18 was a general session meeting consisting of a scientific component. The scientific discussions were focused on study design issues and review of cocaine infusion methods. Four NIDA grantees presented data and/or applications of pharmacokinetic/pharmacodynamic cocaine profiles to cocaine infusion methods. Presenters were: Suzette Evans, Ph.D. (Columbia University); George Bigelow, Ph.D. (Johns Hopkins University); Reese Jones, M.D. (UCSF) and Charles O'Brien, M.D., Ph.D. (University of Pennsylvania). On June 19 the subcommittees conducted meetings in the following areas: compound identification; protocol review; pharmacokinetics; design/methods; data management; and psychosocial/behavioral therapies.


Cocaine Clinical Trials Database

The MDD Cocaine Clinical Program has refined the Cocaine Clinical Trials Database and presented the database as a poster at CPDD. The database summarizes data from MDD sponsored clinical trials which have been completed and analyzed.


Multi-Center Protocols at MDRUs

Four clinical multi center protocols at the new Medications Development Research Units (MDRUs, located in Department of Veterans Affairs medical centers) with bupropion, nefazadone, fenfluramine and methylphenidate are in the final stages of revision. All have IRB approvals and patient enrollment is anticipated by October 1, 1996.


Supplements to VA MDRU Studies

Two supplemental studies within the VA MDRU program were approved and funded, one involving human hepatic metabolic pathways to predict potential toxic interaction with medications for cocaine dependence, the other involving PET imaging of dopamine system ligands in cocaine dependent patients.


Multi-Site Trial of Buprenorphine

Paul Fudala, Ph.D. (VA Cooperative Studies Program and University of Pennsylvania) is co-directing with MDD, NIDA (Peter Bridge, M.D.) a multi-site trial of buprenorphine combined with naloxone.


On-Site Reviews of In-Vitro Screening Contracts

MDD utilized expert consultants for on-site reviews of two of its in vitro screening contracts. A contract focusing on the dopamine transporter is located at Oregon Health Sciences University and was visited by Drs. Michael Kuhar, Gary Rudnik, Ken Johnson, Zdenek Pristupa, Deborah Mash, Beth Hoffman, and Maarten Reith. The screening contract at SRI focusses on a variety of other targets and incorporates functional assays to identify compounds as either agonists or antagonists at specific receptor sites. SRI was visited by Drs. Dmitri Grigoriadis, Bob Luedtke, and Richard Mailman.


Structure Activity Relationship (SAR) Committee

On April 5, the MDD Cocaine Treatment Discovery Team formed a Structure Activity Relationship (SAR) Committee in response to the recommendations of expert consultants for an increased role of SAR in drug discovery. The role of the committee is to strategically evaluate compounds in the database to recommend and facilitate rapid testing and to maximize cost-effectiveness of the CTDP testing program. The Committee has focused on classifying all compounds in the data base to evaluate physico-chemical relationships to:
recommend compounds for in vitro testing (BAT)
request from chemists additional synthesis of compounds targeted for further testing.
correlate in vitro results with physico-chemical features
and recommend compounds to proceed to animal testing based correlations.

Incorporate all data into one database and reporting software.

Obtain computer modeling resources for structural and energy relations to biological activity (presently done manually-at best approximation).


Health Services Research Resource Center

NIDA's Health Services Research Resource Center has accomplished several tasks, including the development of annotated bibliographies to support research in the areas of treatment effectiveness, financing, alternative delivery systems, cost-benefit and cost-effectiveness analysis, costs and benefits of treatment, and economics of drug treatment.


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