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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cocaine-Related Disorders; Substance-Related Disorders	Drug: Cabergoline; Drug: Placebo	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence
Study Start Date :	June 2001
Actual Study Completion Date :	April 2004

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Cabergoline; Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.	Drug: Cabergoline; Other Name: Dostinex
Placebo Comparator: Placebo; Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.	Drug: Placebo; sugar pill manufactured to mimic cabergoline 05mg tablet

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, California
Torrance Clinic
Torrance, California, United States, 90502
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of California, Los Angeles

Investigators

Principal Investigator:	Steve Shoptaw, Ph.D.	Friends Research Institute, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033111 History of Changes
Obsolete Identifiers:	NCT00024895
Other Study ID Numbers:	NIDA-CTO-0007-1
First Posted:	April 8, 2002
Last Update Posted:	January 12, 2017
Last Verified:	October 2016

Additional relevant MeSH terms:

Disease; Cocaine-Related Disorders; Substance-Related Disorders; Pathologic Processes; Chemically-Induced Disorders; Mental Disorders; Cocaine; Cabergoline; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents	Peripheral Nervous System Agents; Vasoconstrictor Agents; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Antineoplastic Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agonists