Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1
Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence
1 other identifier
interventional
269
1 country
16
Brief Summary
The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 5, 2002
CompletedFirst Posted
Study publicly available on registry
April 8, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedJanuary 12, 2017
May 1, 2009
1.8 years
April 5, 2002
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weekly mean proportion of cocaine non-use days
Measured reductions in cocaine and other drug use
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Additional Criteria available during the screening process at the site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Drug Abuse (NIDA)lead
- Somerset Pharmaceuticalscollaborator
Study Sites (16)
Tucson VA Medical Center
Tucson, Arizona, 85723, United States
Haight-Ashbury Free Clinic
Berkeley, California, 94704, United States
Friends Research Institute-2
Los Angeles, California, 90025, United States
Friends Research Institute
Los Angeles, California, 90025, United States
San Francisco General Hosptial
San Francisco, California, 94110, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Denver VA Medical Center
Denver, Colorado, 80220, United States
New Orleans VA Medical Center
New Orleans, Louisiana, 70112, United States
VA Maryland Healthcare System
Baltimore, Maryland, 21201, United States
Wayne State University
Detroit, Michigan, 48207, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
Medical University of South Carolina
Charleston, South Carolina, 29425 742, United States
VA North Texas Health Care System
Dallas, Texas, 75216, United States
University of Texas Hlth Sci Ctr Houston
Houston, Texas, 77030, United States
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148, United States
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
Related Publications (1)
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. doi: 10.1016/j.drugalcdep.2006.04.010. Epub 2006 May 30.
PMID: 16730924RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed Elkashef, MD
National Institute on Drug Abuse (NIDA)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 5, 2002
First Posted
April 8, 2002
Study Start
March 1, 2001
Primary Completion
December 1, 2002
Last Updated
January 12, 2017
Record last verified: 2009-05