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

Substance-Related Disorders Clinical Trial

Official title:

Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033111
• Other study ID #: NIDA-CTO-0007-1
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2002
• Last updated: January 11, 2017
• Start date: June 2001
• Est. completion date: April 2004

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00024895

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease
• Substance-Related Disorders

Intervention

Drug:
• Cabergoline

• Placebo
sugar pill manufactured to mimic cabergoline 05mg tablet

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Torrance Clinic	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence	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.	Week 12	No
Secondary	Reduction in cocaine use	Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels	12 weeks	Yes