Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

July 7, 2016 updated by: University of California, Los Angeles

Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)

The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, baclofen is tested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

16-week participation plus a 2 week lead in period. Participants are assigned randomly to placebo or baclofen. Participant attend group meetings 3 x/week.

Study Type

Interventional

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
      • Los Angeles, California, United States, 90025
        • Friends Research Institute

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

M/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Retention
Cocaine use
Cocaine craving
Psychosocial progress

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)

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

October 1, 1997

Primary Completion (ACTUAL)

May 1, 1999

Study Registration Dates

First Submitted

September 20, 1999

First Submitted That Met QC Criteria

September 20, 1999

First Posted (ESTIMATE)

September 21, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-09260-6
  • P50DA009260 (U.S. NIH Grant/Contract)
  • P50-09260-6

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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