A Study of Cabergoline for the Treatment of Cocaine Dependence - 1
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| ClinicalTrials.gov Identifier: NCT00033111 |
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Recruitment Status :
Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
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Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
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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 |
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 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 |
Resource links provided by the National Library of Medicine
| 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 |
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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 |
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
Information from the National Library of Medicine
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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.
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
| 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. |
| 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 |
| 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 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 |