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

Condition	Treatment or Intervention	Phase
Cocaine-Related Disorders	Drug: Selegiline	Phase III

Further Study Details: 

Expected Total Enrollment:  269

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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Arizona
      Tucson VA Medical Center, Tucson,  Arizona,  85723,  United States
California
      Friends Research Institute-2, Los Angeles,  California,  90025,  United States
      Haight-Ashbury Free Clinic, Berkeley,  California,  94704,  United States
      San Francisco General Hosptial, San Francisco,  California,  94110,  United States
      San Francisco VA Medical Center, San Francisco,  California,  94121,  United States
      Friends Research Institute, Los Angeles,  California,  90025,  United States
Colorado
      Denver VA Medical Center, Denver,  Colorado,  80220,  United States
Louisiana
      New Orleans VA Medical Center, New Orleans,  Louisiana,  70112,  United States
Maryland
      VA Maryland Healthcare System, Baltimore,  Maryland,  21201,  United States
Michigan
      Wayne State University, Detroit,  Michigan,  48207,  United States
Ohio
      Cincinnati VA Medical Center, Cincinnati,  Ohio,  45220,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425 742,  United States
Texas
      University of Texas Hlth Sci Ctr Houston, Houston,  Texas,  77030,  United States
      VA North Texas Health Care System, Dallas,  Texas,  75216,  United States
Utah
      Salt Lake City VA Medical Center, Salt Lake City,  Utah,  84148,  United States
Washington
      VA Puget Sound Health Care System, Seattle,  Washington,  98108,  United States

Study chairs or principal investigators

Liza Gorgon, M.A.,  Principal Investigator,  University of Pennsylvania   

Study ID Numbers:  NIDA-CSP-1019-1
Record last reviewed:  May 2004
Last Updated:  November 18, 2004
Record first received:  April 5, 2002
ClinicalTrials.gov Identifier:  NCT00032929
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08