Tryptophan and Behavior Therapy for Cocaine Abuse - 1

Cocaine-Related Disorders Clinical Trial

Official title:

Tryptophan and Behavior Therapy for Cocaine Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000324
• Other study ID #: NIDA-10754-1
• Secondary ID: R01-10754-1
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: March 1997
• Est. completion date: April 2001

Study information

• Verified date: August 2005
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Tryptophan

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects
Primary	Retention
Primary	Cocaine use
Primary	Cocaine craving
Primary	Other drug use
Primary	Psychosocial functioning