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Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

Phase 3
Completed
Conditions
Cocaine-Related Disorders
Registration Number
NCT00032929
Lead Sponsor
National Institute on Drug Abuse (NIDA)
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
269
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Weekly mean proportion of cocaine non-use days
Measured reductions in cocaine and other drug use
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

Tucson VA Medical Center

🇺🇸

Tucson, Arizona, United States

Haight-Ashbury Free Clinic

🇺🇸

Berkeley, California, United States

Friends Research Institute-2

🇺🇸

Los Angeles, California, United States

Friends Research Institute

🇺🇸

Los Angeles, California, United States

San Francisco General Hosptial

🇺🇸

San Francisco, California, United States

San Francisco VA Medical Center

🇺🇸

San Francisco, California, United States

Denver VA Medical Center

🇺🇸

Denver, Colorado, United States

New Orleans VA Medical Center

🇺🇸

New Orleans, Louisiana, United States

VA Maryland Healthcare System

🇺🇸

Baltimore, Maryland, United States

Wayne State University

🇺🇸

Detroit, Michigan, United States

Scroll for more (6 remaining)
Tucson VA Medical Center
🇺🇸Tucson, Arizona, United States

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