Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 5, 2002

Last Updated Date

May 14, 2009

Start Date ^ICMJE

March 2001

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weekly mean proportion of cocaine non-use days
Measured reductions in cocaine and other drug use

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00032929 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

Official Title ^ICMJE

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

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).

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Selegiline

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

269

Completion Date

December 2002

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00032929

Responsible Party

Liza Gorgon, National Institute on Drug Abuse

Study ID Numbers ^ICMJE

NIDA-CSP-1019-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Somerset Pharmaceuticals

Investigators ^ICMJE

Study Chair:

Ahmed Elkashef, MD

National Institute on Drug Abuse (NIDA)

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP