Clinical trial NCT00032929: Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1
Official title: Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Somerset Pharmaceuticals
First posted: 2002-04-08
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.

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 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.

Primary outcomes:
measure: Weekly mean proportion of cocaine non-use days
measure: Measured reductions in cocaine and other drug use
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson VA Medical Center
state: Arizona
city: Berkeley
country: United States
facility: Haight-Ashbury Free Clinic
state: California
city: Los Angeles
country: United States
facility: Friends Research Institute-2
state: California
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
city: San Francisco
country: United States
facility: San Francisco General Hosptial
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: New Orleans
country: United States
facility: New Orleans VA Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: VA Maryland Healthcare System
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Houston
country: United States
facility: University of Texas Hlth Sci Ctr Houston
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake City VA Medical Center
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Ahmed Elkashef, MD
role: STUDY_CHAIR
References:
citation: 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.