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Completed

NCT Number: NCT00032929

Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

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

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tucson VA Medical Center, Tucson, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selegiline

Drug

Primary outcomes

  1. Weekly mean proportion of cocaine non-use days

  2. Measured reductions in cocaine and other drug use

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • Somerset Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
First posted
Apr 8, 2002
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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