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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033111
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Substance-Related Disorders Drug: Cabergoline Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence
Study Start Date : June 2001
Actual Study Completion Date : April 2004

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033111


Locations
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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
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Principal Investigator: Steve Shoptaw, Ph.D. Friends Research Institute, Inc.
More Information
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00033111    
Obsolete Identifiers: NCT00024895
Other Study ID Numbers: NIDA-CTO-0007-1
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016
Additional relevant MeSH terms:
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Disease
Cocaine-Related Disorders
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Cabergoline
 Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs