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Completed

NCT Number: NCT00033111

A Study of Cabergoline for the Treatment of Cocaine Dependence - 1

The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence

Completed

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Torrance Clinic, Torrance, California, United States

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About this study

To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. This is a DB, placebo-controlled, parallel group design study where subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control.

Exclusion criteria

Additional criteria available during screening at the site.

Treatment and study plan

cabergoline

Drug

Other names: Dostinex

Placebo

Drug

sugar pill manufactured to mimic cabergoline 05mg tablet

Primary outcomes

  1. To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence

    Time frame: Week 12

    Success in the reduction of cocaine use was determined by comparing cocaine non-use days (self-report confirmed or disproved by urine BE level at each study visit) expressed as the weekly mean proportion of non-use days to the total number of non-missing study days that week.

Secondary outcomes

  1. Reduction in cocaine use

    Time frame: 12 weeks

    Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence

Important dates

Study start
2001
Study completion
2004
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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