Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Baclofen

+ Placebo

DrugOther
Who is being recruted

Mental Disorders+1

+ Substance-Related Disorders

+ Cocaine-Related Disorders

From 18 to 99 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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

Official TitleMulti-Center Trial of Baclofen for the Treatment of Cocaine Dependence 
NCT00431938NCT00082485
Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersCocaine-Related DisordersChemically-Induced Disorders

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

San Francisco General Hosptial

San Francisco, United StatesSee the location
Suspended

Torrance Site

Torrance, United States
Suspended

Denver VA Medical Center

Denver, United States
Suspended

VA Maryland Healthcare System

Baltimore, United States
Completed8 Study Centers