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

This study has been completed.

First Received on September 20, 1999. Last Updated on August 16, 2005 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000303

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Baclofen

U.S. FDA Resources

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

Primary Outcome Measures:

Retention
Cocaine use
Cocaine craving
Psychosocial progress

Estimated Enrollment:	0
Study Start Date:	October 1997

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

M/F ages 18-65. cocaine dependence according to 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 ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000303

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000303 History of Changes
Other Study ID Numbers:	NIDA-09260-6, P50-09260-6
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012