Tryptophan and Behavior Therapy for Cocaine Abuse - 1

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Johns Hopkins University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000324

Purpose

The purpose of this study is to assess the efficacy of tryptophan vs. placebo, and voucher payments vs. a control condition, in the treatment of cocaine dependence.

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

Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Tryptophan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:	Tryptophan and Behavior Therapy for Cocaine Abuse

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

Primary Outcome Measures:

Side effects
Retention
Cocaine use
Cocaine craving
Other drug use
Psychosocial functioning

Estimated Enrollment:	200
Study Start Date:	March 1997
Estimated Study Completion Date:	April 2001

Detailed Description:

This clinical trial uses a 2 by 2 design to compare tryptophan to placebo, and voucher incentives vs. a control condition, in the outpatient treatment of cocaine dependence- using a relapse prevention model of treatment intervention.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cocaine dependent

Exclusion Criteria:

Physically dependent on drugs of abuse other than cocaine
Significant medical or psychiatric illness (besides substance abuse disorder)
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000324

Locations

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators

Principal Investigator:

Eric C Strain, M.D.

Johns Hopkins University

More Information

Publications:

Jones H.E., Johnson, R.E., Bigelow G.E., Strain E.C. Differences at treatment entry between opioid-dependent and cocaine-dependent males and females. Addictive Disorders and Their Treatment 3:110-121, 2004.

Jones HE, Johnson RE, Bigelow GE, Silverman K, Mudric T, Strain EC. Safety and efficacy of L-tryptophan and behavioral incentives for treatment of cocaine dependence: a randomized clinical trial. Am J Addict. 2004 Oct-Dec;13(5):421-37.

Study ID Numbers:	NIDA-10754-1, R01-10754-1
Study First Received:	September 20, 1999
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00000324
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Tryptophan
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Therapeutic Uses
Psychotropic Drugs
Antidepressive Agents, Second-Generation

Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009