NCT00032929CompletedPhase 3
Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence
National Institute on Drug Abuse (NIDA)32 sites in 1 country269 target enrollmentStarted: March 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 269
- Locations
- 32
- Primary Endpoint
- Weekly mean proportion of cocaine non-use days
Study Overview
Brief Summary
The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.
Detailed Description
The study objectives are to assess the efficacy and safety of the Selegiline Transdermal System (STS) in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that selegiline treatment compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male/Female
- •At least 18 years of age
- •DSM-4 diagnosis of cocaine dependence
- •Ability to understand and provide written consent
- •Female subjects must use acceptable birth control
Exclusion Criteria
- •Additional Criteria available during the screening process at the site.
Outcomes
Primary Outcomes
Weekly mean proportion of cocaine non-use days
Measured reductions in cocaine and other drug use
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (32)
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