A Study of Cabergoline for the Treatment of Cocaine Dependence – 1

Overview

The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence

Full Title of Study: “Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)

Detailed Description

To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. This is a DB, placebo-controlled, parallel group design study where subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week follow-up.

Interventions

  • Drug: Cabergoline
  • Drug: Placebo
    • sugar pill manufactured to mimic cabergoline 05mg tablet

Arms, Groups and Cohorts

  • Active Comparator: Cabergoline
    • Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.
  • Placebo Comparator: Placebo
    • Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence
    • Time Frame: Week 12
    • Success in the reduction of cocaine use was determined by comparing cocaine non-use days (self-report confirmed or disproved by urine BE level at each study visit) expressed as the weekly mean proportion of non-use days to the total number of non-missing study days that week.

Secondary Measures

  • Reduction in cocaine use
    • Time Frame: 12 weeks
    • Measured by the weekly mean proportion of non-use days according to the subject’s self report without regard to BE levels

Participating in This Clinical Trial

Inclusion Criteria

Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control. Exclusion Criteria:

Additional criteria available during screening at the site.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Institute on Drug Abuse (NIDA)
  • Collaborator
    • University of California, Los Angeles
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Steve Shoptaw, Ph.D., Principal Investigator, Friends Research Institute, Inc.

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