search
Back to results

Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Selegiline
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tucson VA Medical Center
  • Haight-Ashbury Free Clinic
  • Friends Research Institute-2
  • Friends Research Institute
  • San Francisco General Hosptial
  • San Francisco VA Medical Center
  • Denver VA Medical Center
  • New Orleans VA Medical Center
  • VA Maryland Healthcare System
  • Wayne State University
  • Cincinnati VA Medical Center
  • Medical University of South Carolina
  • VA North Texas Health Care System
  • University of Texas Hlth Sci Ctr Houston
  • Salt Lake City VA Medical Center
  • VA Puget Sound Health Care System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2002
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Somerset Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00032929
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Somerset Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Selegiline
Primary Outcome Measure Information:
Title
Weekly mean proportion of cocaine non-use days
Title
Measured reductions in cocaine and other drug use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elkashef, MD
Organizational Affiliation
National Institute on Drug Abuse (NIDA)
Official's Role
Study Chair
Facility Information:
Facility Name
Tucson VA Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Haight-Ashbury Free Clinic
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Friends Research Institute-2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
San Francisco General Hosptial
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
New Orleans VA Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
VA Maryland Healthcare System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425 742
Country
United States
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
University of Texas Hlth Sci Ctr Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Salt Lake City VA Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16730924
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.
Results Reference
result

Learn more about this trial

Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

We'll reach out to this number within 24 hrs