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Tryptophan and Behavior Therapy for Cocaine Abuse - 1

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00000324
First received: September 20, 1999
Last updated: November 3, 2005
Last verified: August 2005
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Tryptophan and Behavior Therapy for Cocaine Abuse

Resource links provided by NLM:

U.S. FDA Resources

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.

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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Tryptophan
Antidepressive Agents, Second-Generation
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013