Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

Cocaine-Related Disorders Clinical Trial

Official title:

Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032929
• Other study ID #: NIDA-CSP-1019-1
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2002
• Last updated: January 11, 2017
• Start date: March 2001

Study information

• Verified date: May 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Other known NCT identifiers

• NCT00007553
• NCT00024700

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Selegiline

Locations

Country	Name	City	State
United States	VA Maryland Healthcare System	Baltimore	Maryland
United States	Haight-Ashbury Free Clinic	Berkeley	California
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	VA North Texas Health Care System	Dallas	Texas
United States	Denver VA Medical Center	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	University of Texas Hlth Sci Ctr Houston	Houston	Texas
United States	Friends Research Institute	Los Angeles	California
United States	Friends Research Institute-2	Los Angeles	California
United States	New Orleans VA Medical Center	New Orleans	Louisiana
United States	Salt Lake City VA Medical Center	Salt Lake City	Utah
United States	San Francisco General Hosptial	San Francisco	California
United States	San Francisco VA Medical Center	San Francisco	California
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	Tucson VA Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Somerset Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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 D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly mean proportion of cocaine non-use days
Primary	Measured reductions in cocaine and other drug use