Baclofen for the Treatment of Cocaine Dependence - 1

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

Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence

The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence

Study Type

Interventional

Enrollment (Actual)

160

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
      • San Francisco, California, United States, 94110
        • San Francisco General Hosptial
      • Torrance, California, United States, 90502
        • Torrance Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • VA Maryland Healthcare System
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104 6178
        • U of Penn School of Medicine
    • Texas
      • San Antonio, Texas, United States, 78284 4404
        • South TX VA Health Care System
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Salt Lake City VA Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042 3300
        • Institute of Resch & Educ Inova Fairfax Hospital

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:

  • Subject must have DSM-IV diagnosis of cocaine dependence.
  • Subject must be seeking treatment for cocaine dependence.
  • Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.

Exclusion Criteria:

  • Please contact site for more information.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Other: Placebo
Placebo
Active Comparator: 1
Drug: Baclofen
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effects of medication on cocaine craving

Collaborators and Investigators

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

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Liza Gorgon, M.A., VA Maryland Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2004

Primary Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

May 11, 2004

First Submitted That Met QC Criteria

May 11, 2004

First Posted (Estimate)

May 12, 2004

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CSP-1021-1

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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