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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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.

Intervention(s) in this Clinical Trial

• Drug: Cabergoline

Primary Measures

• New Use
• reduction of severity of cocaine dependence

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00033111

Study ID Number: NIDA-CTO-0007-1

ClinicalTrials.gov Identifier: NCT00033111

Health Authority: United States: Food and Drug Administration