Clincosm LogoSign in Get a demo

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

Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Completed
CT.gov ID
NCT00033111
Collaborator
University of California, Los Angeles (Other)
140
Enrollment
2
Locations
2
Arms
34
Duration (Months)
70
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence
Study Start Date :
Jun 1, 2001
Actual Study Completion Date :
Apr 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cabergoline

Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.

Drug: Cabergoline
Other Names:
  • Dostinex

    		•
    Placebo Comparator: Placebo

    Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.

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

    Outcome Measures

    Primary Outcome Measures

    1. To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence [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 Outcome Measures

    1. Reduction in cocaine use [12 weeks]

      Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Torrance Clinic Torrance California United States 90502
    2 Medical University of South Carolina Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • National Institute on Drug Abuse (NIDA)
    • University of California, Los Angeles

    Investigators

    • Principal Investigator: Steve Shoptaw, Ph.D., Friends Research Institute, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute on Drug Abuse (NIDA)
    ClinicalTrials.gov Identifier:
    NCT00033111
    Other Study ID Numbers:
    • NIDA-CTO-0007-1
    • NCT00024895
    First Posted:
    Apr 8, 2002
    Last Update Posted:
    Jan 12, 2017
    Last Verified:
    Oct 1, 2016
    Additional relevant MeSH terms:
    Disease
    Cocaine-Related Disorders
    Substance-Related Disorders
    Cabergoline

    Study Results

    No Results Posted as of Jan 12, 2017