Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Cocaine-Related Disorders

Treatments: Drug: Selegiline

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00032929

NIDA-CSP-1019-1

Details and patient eligibility

About

The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.

Full 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).

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind