Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

NCT ID: NCT00032929

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Cocaine-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Selegiline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Somerset Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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National Institute on Drug Abuse

Principal Investigators

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Ahmed Elkashef, MD

Role: STUDY_CHAIR

National Institute on Drug Abuse (NIDA)

Locations

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Tucson VA Medical Center

Tucson, Arizona, United States

Site Status

Haight-Ashbury Free Clinic

Berkeley, California, United States

Site Status

Friends Research Institute-2

Los Angeles, California, United States

Site Status

Friends Research Institute

Los Angeles, California, United States

Site Status

San Francisco General Hosptial

San Francisco, California, United States

Site Status

San Francisco VA Medical Center

San Francisco, California, United States

Site Status

Denver VA Medical Center

Denver, Colorado, United States

Site Status

New Orleans VA Medical Center

New Orleans, Louisiana, United States

Site Status

VA Maryland Healthcare System

Baltimore, Maryland, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

VA North Texas Health Care System

Dallas, Texas, United States

Site Status

University of Texas Hlth Sci Ctr Houston

Houston, Texas, United States

Site Status

Salt Lake City VA Medical Center

Salt Lake City, Utah, United States

Site Status

VA Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16730924 (View on PubMed)

Other Identifiers

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NIDA-CSP-1019-1

Identifier Type: -

Identifier Source: org_study_id

NCT00007553

Identifier Type: -

Identifier Source: nct_alias

NCT00024700

Identifier Type: -

Identifier Source: nct_alias

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