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Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

This study has been completed.
Somerset Pharmaceuticals
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: April 5, 2002
Last updated: January 11, 2017
Last verified: May 2009
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Enrollment: 269
Study Start Date: March 2001
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
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).

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00032929

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
Study Chair: Ahmed Elkashef, MD National Institute on Drug Abuse (NIDA)
  More Information

Responsible Party: Liza Gorgon, National Institute on Drug Abuse Identifier: NCT00032929     History of Changes
Obsolete Identifiers: NCT00007553, NCT00024700
Other Study ID Numbers: NIDA-CSP-1019-1
Study First Received: April 5, 2002
Last Updated: January 11, 2017

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine Dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on April 28, 2017