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

This study has been completed.

First Received: April 5, 2002 Last Updated: July 21, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of California, Los Angeles
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033111

Purpose

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

Condition	Intervention	Phase
Cocaine-Related Disorders Substance-Related Disorders	Drug: Cabergoline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence

Resource links provided by NLM:

Drug Information available for: Cabergoline Cabergoline diphosphate

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

New Use
reduction of severity of cocaine dependence

Estimated Enrollment:	140
Study Start Date:	June 2001
Study Completion Date:	April 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033111

Locations

United States, California
Torrance Clinic
Torrance, California, United States, 90502
United States, South Carolina
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.

More Information

No publications provided

Study ID Numbers:	NIDA-CTO-0007-1
Study First Received:	April 5, 2002
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00033111 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cocaine-Related Disorders
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Disorders of Environmental Origin
Antiparkinson Agents

Dopamine Agonists
Pharmacologic Actions
Pathologic Processes
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Dopamine Agents
Cabergoline
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009