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

Phase 2

Completed

• Conditions: Cocaine-Related Disorders; Substance-Related Disorders
• Interventions: Drug: Cabergoline; Drug: Placebo

• Registration Number: NCT00033111
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

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 Timeline

• Study Start: 2001-06
• Study First Submitted: 2002-04-05
• Study First Submitted QC: 2002-04-05
• Study First Posted: 2002-04-08
• Study Completion: 2004-04
• Status Verified: 2016-10
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabergoline	Cabergoline	Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.
Placebo	Placebo	Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Torrance Clinic; 🇺🇸 Torrance, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States