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.
For additional information about NIDA send e-mail to Information@nida.nih.gov
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