Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

This study has been completed.

First Received: April 5, 2002 Last Updated: May 14, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	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

Resource links provided by NLM:

Drug Information available for: Selegiline Selegiline hydrochloride

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
Estimated Study Completion Date:	December 2002
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
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

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:

Elkashef A, Fudala PJ, Gorgon L, Li SH, Kahn R, Chiang N, Vocci F, Collins J, Jones K, Boardman K, Sather M. Double-blind, placebo-controlled trial of selegiline transdermal system (STS) for the treatment of cocaine dependence. Drug Alcohol Depend. 2006 Dec 1;85(3):191-7. Epub 2006 May 30.

Responsible Party:	National Institute on Drug Abuse ( Liza Gorgon )
Study ID Numbers:	NIDA-CSP-1019-1
Study First Received:	April 5, 2002
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00032929 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cocaine-Related Disorders
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Disorders of Environmental Origin
Enzyme Inhibitors
Neuroprotective Agents

Protective Agents
Pharmacologic Actions
Selegiline
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Monoamine Oxidase Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009