Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

269

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Tucson VA Medical Center
    • California
      • Berkeley, California, United States, 94704
        • Haight-Ashbury Free Clinic
      • Los Angeles, California, United States, 90025
        • Friends Research Institute
      • Los Angeles, California, United States, 90025
        • Friends Research Institute-2
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center
      • San Francisco, California, United States, 94110
        • San Francisco General Hosptial
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • New Orleans VA Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • VA Maryland Healthcare System
    • Michigan
      • Detroit, Michigan, United States, 48207
        • Wayne State University
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati VA Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425 742
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System
      • Houston, Texas, United States, 77030
        • University of Texas Hlth Sci Ctr Houston
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Salt Lake City VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Somerset Pharmaceuticals

Investigators

  • Study Chair: Ahmed Elkashef, MD, National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (ACTUAL)

December 1, 2002

Study Registration Dates

First Submitted

April 5, 2002

First Submitted That Met QC Criteria

April 5, 2002

First Posted (ESTIMATE)

April 8, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CSP-1019-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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