Cocaine-Related Disorders, Substance-Related Disorders
Conditions
Brief summary
The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
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.
Interventions
DRUGCabergoline
DRUGPlacebo
sugar pill manufactured to mimic cabergoline 05mg tablet
Sponsors
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduction in cocaine use | 12 weeks | Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels |
Countries
United States
Outcome results
None listed