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NCT00292110 · ClinicalTrials.gov registry record · Phase 1
Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management
A Phase 1 study of Cocaine-Related Disorders and Opiate-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT00292110 is a Phase 1 study of Cocaine-Related Disorders and Opiate-Related Disorders that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 140 participants, above the 56-participant average among 15 other Cocaine-Related Disorders trials with a reported enrollment target (150% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00292110, a Phase 1 study of Cocaine-Related Disorders and Opiate-Related Disorders, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- The treatment of addiction often hinges on preventing relapse into drug-using behaviors, which occurs at high rates even after prolonged abstinence. Some methadone patients continue to abuse cocaine and heroin during treatment, even with extensive psychosocial services. More research is needed to look at the results from earlier studies of continued drug use during methadone treatment, focusing on the results of fixed vs. flexible doses of methadone to reduce the likelihood of continued drug use and the role of monetary vouchers as an incentive to continue abstinence from illicit substances. Objectives: \- To determine if the combination of flexible methadone dosing and voucher-based contingency management can improve rates of abstinence from heroin and cocaine. Eligibility: \- Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine and/or heroin). Design: * The study will last 40 weeks. After the initial screening, participants will receive daily methadone and weekly drug counseling sessions that will continue throughout the study. * After 6 weeks of methadone treatment, participants who continue to use heroin and cocaine will be randomized to one of four groups for 16 weeks of study. Each group will receive a flexible or fixed dose of methadone, and one of two contingency management conditions. * Flexible-dose participants will receive individualized dose increases, based on drug use and withdrawal. Fixed-dose participants will be set at a specific dose of methadone that will not be changed. * The two contingency management conditions will be monetary vouchers given for regular cocaine-negative urine samples, or vouchers independent of urine cocaine screen results. * After the study phase, participants will have 10 weeks of standard individual counseling and stable doses of methadone. Urine samples will continue to be collected, but no vouchers will be given. * At the end of the study, participants will have
Conditions Studied
Interventions
- DRUG Methadone
- BEHAVIORAL Contingency Management
- DRUG Methadone dose
- BEHAVIORAL Contingency Management/Noncontingent Incentives
Study Locations (1)
Maryland
- National Institute on Drug Abuse - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2004-02-01 |
| Est. Completion | 2013-08-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00292110
The ClinicalTrials.gov registry entry for NCT00292110 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 56-participant average among 15 other Cocaine-Related Disorders trials with a reported enrollment target (150% higher). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cocaine-Related Disorders appearing as the primary indexed condition, and to 4 interventions - of which Methadone is the first listed.
NCT00292110 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00292110 about?
NCT00292110 is a clinical study titled "Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management". Background: \- The treatment of addiction often hinges on preventing relapse into drug-using behaviors, which occurs at high rates even after prolonged abstinence. Some methadone patients continue to abuse cocaine and heroin during treatment, even with extensive psychosocial services. More research...
What is the current status of trial NCT00292110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2004-02-01. Estimated completion is 2013-08-09.
What conditions does trial NCT00292110 study?
This clinical trial studies the following conditions: Cocaine-Related Disorders, Opiate-Related Disorders.
What interventions are being tested in trial NCT00292110?
The interventions under investigation include: Methadone (DRUG), Contingency Management (BEHAVIORAL), Methadone dose (DRUG), Contingency Management/Noncontingent Incentives (BEHAVIORAL).
Who is sponsoring clinical trial NCT00292110?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00292110 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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