Name of Project: CTO: Phase 2, Double-blind,
Placebo-controlled Trial of Cabergoline for the Treatment of Cocaine
Dependence
Principal Investigator: Thomas Newton, M.D.
Co-Principal Investigators: Walter Ling, M.D., Steven Shoptaw, Ph.D., Richard A. Rawson, Ph.D., Donnie W. Watson, Ph.D., Jonathan Harry, M.D., and Robert Axelrod, M.D.
Project Director: Donnie Watson, Ph. D.
Funding Agency: National Institute on Drug Abuse
(NIDA)
Funding Period: February 2000-February 2005
Scope of Project: The purpose of this study is
to assess the efficacy and safety of cabergoline in reducing cocaine
use in subjects with cocaine dependence. It is hypothesized that
cabergoline treatment, compared to placebo, will be associated
with fewer days of cocaine use as assessed by self-report and
confirmed with urine assays for benzoylecgonine (BE). This is
a double-blind, placebocontrolled, parallel-group design study
in which, after screening and a two-week baseline period, subjects
will be equally randomly assigned to receive either 0.5 mg cabergoline
or placebo once per week for 12 weeks, with a follow-up assessment
four weeks after treatment completion. The subjects (N = 140),
who will meet Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition (DSM-IV), criteria for cocaine dependence, as determined
by the Structured Clinical Interview (SCID), will be randomized
into one of two treatment groups (70 per group). Subjects who
are at least 18 years old, who
provide at least one urine BE positive specimen during the two-week
baseline period, and who have the ability to understand and provide
written informed consent will be included.
For more information, contact Thomas
Newton.
Last updated - 07/02/2003