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Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

This study has been completed.
Sponsor:
Collaborator:
Somerset Pharmaceuticals
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00032929
First received: April 5, 2002
Last updated: May 14, 2009
Last verified: May 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

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

Publications:

Responsible Party: Liza Gorgon, National Institute on Drug Abuse
ClinicalTrials.gov 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: May 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Selegiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on May 16, 2013