Baclofen for the Treatment of Cocaine Dependence - 1 - Full Text View

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

ChemIDplus related topics:

8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Baclofen

U.S. FDA Resources

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

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

Responsible Party:	National Institute on Drug Abuse ( Liza Gorgon )
Study ID Numbers:	NIDA-CSP-1021-1
First Received:	May 11, 2004
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00082485
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders

Mental Disorders

Baclofen

Substance-Related Disorders

Disorders of Environmental Origin

Cocaine

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

GABA Agonists

Therapeutic Uses

Muscle Relaxants, Central

Physiological Effects of Drugs

GABA Agents

Neuromuscular Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

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