NCT00000324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 1997

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2005

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (6)

  • Side effects

  • Retention

  • Cocaine use

  • Cocaine craving

  • Other drug use

  • Psychosocial functioning

Interventions

TryptophanDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cocaine dependent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Related 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.

    BACKGROUND

  • 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.

    PMID: 15764421BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Tryptophan

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Eric C Strain, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

March 1, 1997

Study Completion

April 1, 2001

Last Updated

January 12, 2017

Record last verified: 2005-08

Locations

US(1)