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Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

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ClinicalTrials.gov Identifier: NCT00032929
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
Somerset Pharmaceuticals
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Selegiline Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence
Study Start Date : March 2001
Actual Primary Completion Date : December 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Weekly mean proportion of cocaine non-use days
  2. Measured reductions in cocaine and other drug use

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032929

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United States, Arizona
Tucson VA Medical Center
Tucson, Arizona, United States, 85723
United States, California
Haight-Ashbury Free Clinic
Berkeley, California, United States, 94704
Friends Research Institute-2
Los Angeles, California, United States, 90025
Friends Research Institute
Los Angeles, California, United States, 90025
San Francisco General Hosptial
San Francisco, California, United States, 94110
San Francisco VA Medical Center
San Francisco, California, United States, 94121
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
VA North Texas Health Care System
Dallas, Texas, United States, 75216
University of Texas Hlth Sci Ctr Houston
Houston, Texas, United States, 77030
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
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Somerset Pharmaceuticals
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Study Chair: Ahmed Elkashef, MD National Institute on Drug Abuse (NIDA)
Publications of Results:
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Responsible Party: Liza Gorgon, National Institute on Drug Abuse
ClinicalTrials.gov Identifier: NCT00032929    
Obsolete Identifiers: NCT00007553, NCT00024700
Other Study ID Numbers: NIDA-CSP-1019-1
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: May 2009
Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine Dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs