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

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

University of California, Los Angeles

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

April 5, 2002

First Submitted That Met QC Criteria

April 5, 2002

First Posted (Estimate)

April 8, 2002

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTO-0007-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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