Cocaine-Related DisordersPhase 2NCT00000324
Tryptophan and Behavior Therapy for Cocaine Abuse - 1
A Phase 2 study testing Tryptophan in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Tryptophan
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Apr 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cocaine dependent
Who cannot join
- Physically dependent on drugs of abuse other than cocaine
- Significant medical or psychiatric illness (besides substance abuse disorder)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: Tryptophan and Behavior Therapy for Cocaine Abuse
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.
Read the 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.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Tryptophan
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TryptophanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects
Retention
Cocaine use
Cocaine craving
Other drug use
Psychosocial functioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startMar 1997
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Investigators
- Eric C Strain, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000324
- Sponsor's protocol ID
- NIDA-10754-1
- Other IDs
- R01-10754-1
- Status last verified
- Aug 2005
- First submitted
- 20 Sep 1999
- Last updated
- 12 Jan 2017
- Results posted
- No
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. doi: 10.1080/10550490490512753.
PubMed 15764421
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryptophan and Behavior Therapy for Cocaine Abuse
- ClinicalTrials.gov ID
- NCT00000324
- Acronym / sponsor ID
- NIDA-10754-1
- Conditions
- Cocaine-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Study start
- Mar 1997
- Study completion
- Apr 2001
- First posted
- 21 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cocaine dependent
Key exclusion criteria (3 listed)
- Physically dependent on drugs of abuse other than cocaine
- Significant medical or psychiatric illness (besides substance abuse disorder)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tryptophan | Drug | – |
Primary outcome
Side effects
Retention
Cocaine use
Cocaine craving
Other drug use
Psychosocial functioning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- BackgroundJones 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: PubMed 15764421Jones 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric C Strain, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tryptophan in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000324, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.