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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Somerset Pharmaceuticals |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00032929 |
Purpose
The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders |
Drug: Selegiline |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence |
| Enrollment: | 269 |
| Study Start Date: | March 2001 |
| Estimated Study Completion Date: | December 2002 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, Arizona | |
| Tucson VA Medical Center | |
| Tucson, Arizona, United States, 85723 | |
| United States, California | |
| Friends Research Institute-2 | |
| Los Angeles, California, United States, 90025 | |
| Haight-Ashbury Free Clinic | |
| Berkeley, California, United States, 94704 | |
| San Francisco General Hosptial | |
| San Francisco, California, United States, 94110 | |
| San Francisco VA Medical Center | |
| San Francisco, California, United States, 94121 | |
| Friends Research Institute | |
| Los Angeles, California, United States, 90025 | |
| United States, Colorado | |
| Denver VA Medical Center | |
| Denver, Colorado, United States, 80220 | |
| United States, Louisiana | |
| New Orleans VA Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| VA Maryland Healthcare System | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48207 | |
| United States, Ohio | |
| Cincinnati VA Medical Center | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 742 | |
| United States, Texas | |
| University of Texas Hlth Sci Ctr Houston | |
| Houston, Texas, United States, 77030 | |
| VA North Texas Health Care System | |
| Dallas, Texas, United States, 75216 | |
| United States, Utah | |
| Salt Lake City VA Medical Center | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Washington | |
| VA Puget Sound Health Care System | |
| Seattle, Washington, United States, 98108 | |
| Study Chair: | Ahmed Elkashef, MD | National Institute on Drug Abuse (NIDA) |
More Information
| Responsible Party: | National Institute on Drug Abuse ( Liza Gorgon ) |
| Study ID Numbers: | NIDA-CSP-1019-1 |
| Study First Received: | April 5, 2002 |
| Last Updated: | July 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00032929 |
| Health Authority: | United States: Food and Drug Administration |
|
Cocaine-Related Disorders Selegiline Mental Disorders |
Substance-Related Disorders Disorders of Environmental Origin Cocaine |
|
Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Monoamine Oxidase Inhibitors Antiparkinson Agents |
Enzyme Inhibitors Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |
