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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabergoline | Active Comparator | Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks. |
|
| Placebo | Placebo Comparator | Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence | 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in cocaine use | Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels | 12 weeks |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Steve Shoptaw, Ph.D. | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Torrance Clinic | Torrance | California | 90502 | United States | ||
| Medical University of South Carolina |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
sugar pill manufactured to mimic cabergoline 05mg tablet |
|
| Charleston |
| South Carolina |
| 29425 |
| United States |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |