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

NCT ID: NCT00033111

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

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2004-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cocaine-Related Disorders Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cabergoline

Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.

Group Type ACTIVE_COMPARATOR

Cabergoline

Intervention Type DRUG

Placebo

Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sugar pill manufactured to mimic cabergoline 05mg tablet

Interventions

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Cabergoline

Intervention Type DRUG

Placebo

sugar pill manufactured to mimic cabergoline 05mg tablet

Intervention Type DRUG

Other Intervention Names

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Dostinex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Shoptaw, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Torrance Clinic

Torrance, California, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NIDA-CTO-0007-1

Identifier Type: -

Identifier Source: org_study_id

NCT00024895

Identifier Type: -

Identifier Source: nct_alias

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