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

This study has been completed.

Sponsor:

Collaborator:

University of California, Los Angeles

Information provided by (Responsible Party):

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00033111

First received: April 5, 2002

Last updated: January 11, 2017

Last verified: October 2016

History of Changes

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 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
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:

To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence [ Time Frame: 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:

Reduction in cocaine use [ Time Frame: 12 weeks ]
Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels


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

Arms	Assigned Interventions
Active Comparator: Cabergoline Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.	Drug: Cabergoline Other Name: 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

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 to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033111 History of Changes
Obsolete Identifiers:	NCT00024895
Other Study ID Numbers:	NIDA-CTO-0007-1
Study First Received:	April 5, 2002
Last Updated:	January 11, 2017

Additional relevant MeSH terms:


Disease Cocaine-Related Disorders Substance-Related Disorders Pathologic Processes Chemically-Induced Disorders Mental Disorders Cocaine Cabergoline Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents	Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Antineoplastic Agents Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agonists

ClinicalTrials.gov processed this record on August 16, 2017

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