Back to resultsTryptophan and Behavior Therapy for Cocaine Abuse - 1
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tryptophan
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility 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
Sites / Locations
- Johns Hopkins University School of Medicine
Outcomes
Primary Outcome Measures
Side effects
Retention
Cocaine use
Cocaine craving
Other drug use
Psychosocial functioning
Secondary Outcome Measures
Full Information
NCT ID
NCT00000324
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00000324
Brief Title
Tryptophan and Behavior Therapy for Cocaine Abuse - 1
Official Title
Tryptophan and Behavior Therapy for Cocaine Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Johns Hopkins University
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tryptophan
Primary Outcome Measure Information:
Title
Side effects
Title
Retention
Title
Cocaine use
Title
Cocaine craving
Title
Other drug use
Title
Psychosocial functioning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C Strain, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
15764421
Citation
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. doi: 10.1080/10550490490512753.
Results Reference
background
Learn more about this trial
Tryptophan and Behavior Therapy for Cocaine Abuse - 1
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