A Study of Cabergoline for the Treatment of Cocaine Dependence - 1
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ClinicalTrials.gov Identifier: NCT00033111 |
Recruitment Status :
Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cocaine-Related Disorders Substance-Related Disorders | Drug: Cabergoline Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
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Active Comparator: Cabergoline
Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.
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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.
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Drug: Placebo
sugar pill manufactured to mimic cabergoline 05mg tablet |
- 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.
- 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

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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 |
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.

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