Baclofen for the Treatment of Cocaine Dependence - 1

This study has been completed.

First Received: May 11, 2004 Last Updated: May 14, 2009 History of Changes

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00082485

Purpose

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

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Baclofen Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence

Resource links provided by NLM:

Drug Information available for: Baclofen

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Effects of medication on cocaine craving

Enrollment:	160
Study Start Date:	June 2004
Estimated Study Completion Date:	November 2005
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Baclofen Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
2: Placebo Comparator	Other: Placebo Placebo

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082485

Locations

United States, California
San Francisco General Hosptial
San Francisco, California, United States, 94110
Torrance Site
Torrance, California, United States, 90502
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Maryland
VA Maryland Healthcare System
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
U of Penn School of Medicine
Philadelphia, Pennsylvania, United States, 19104 6178
United States, Texas
South TX VA Health Care System
San Antonio, Texas, United States, 78284 4404
United States, Utah
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States, 84148
United States, Virginia
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

More Information

Publications:

Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 May 2; [Epub ahead of print]

Responsible Party:	National Institute on Drug Abuse ( Liza Gorgon )
Study ID Numbers:	NIDA-CSP-1021-1
Study First Received:	May 11, 2004
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00082485 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Neurotransmitter Agents
Mental Disorders
GABA Agonists
Muscle Relaxants, Central

Baclofen
Substance-Related Disorders
Disorders of Environmental Origin
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:

Cocaine-Related Disorders
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Baclofen
Physiological Effects of Drugs
Disorders of Environmental Origin
Neuromuscular Agents
Pharmacologic Actions

Mental Disorders
Muscle Relaxants, Central
Therapeutic Uses
GABA Agonists
Substance-Related Disorders
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009