Baclofen for the Treatment of Cocaine Dependence - 1

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00082485

Collaborator

(none)

160

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders	Drug: Baclofen Other: Placebo	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jul 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

Drug: Baclofen

Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)

Placebo Comparator: 2

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Effects of medication on cocaine craving []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00082485

Other Study ID Numbers:

NIDA-CSP-1021-1
NCT00431938

First Posted:

May 12, 2004

Last Update Posted:

Jan 12, 2017

Last Verified:

Aug 1, 2016

Keywords provided by , ,

Cocaine Dependence

Additional relevant MeSH terms:

Cocaine-Related Disorders

Baclofen

Study Results

No Results Posted as of Jan 12, 2017