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NCT00780702 · ClinicalTrials.gov registry record · Phase 1
Aripiprazole for Prevention of Relapse to Cocaine Use in Methadone-Maintenance Patients
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT00780702 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 41 participants.
The verdict
NCT00780702, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
Background: * The effectiveness of methadone maintenance for treatment of heroin addiction has been well established. However, patients maintained on methadone may relapse to cocaine use, even when they are enrolled in a comprehensive treatment program. Relapse has been attributed to several factors, including drug-associated environmental stimuli. * Aripiprazole is a drug used to treat schizophrenia and bipolar disorder, but it may have other uses. Research has shown that aripiprazole can reduce cocaine-seeking behavior in rats, and it has been investigated for use in treating amphetamine dependence. More research is needed to determine whether aripiprazole can prevent relapse to cocaine use in patients being treated with methadone. Objectives: \- To determine whether aripiprazole prevents relapse to cocaine use more effectively than placebo in cocaine-abstinent patients maintained on methadone. Eligibility: \- Individuals between 18 and 60 years of age who are current cocaine users seeking methadone treatment. Design: * The study will last up to 41 weeks, with four phases of treatment and a follow-up evaluation. Three times a week, participants will be asked to report illicit drug use and provide urine and breath samples. Throughout the study, participants will receive individual counseling in weekly 40 60 minute sessions. Other samples and tests will be scheduled as required by the study researchers. * Patients will be stabilized on daily methadone over the first 14 days of the study. * Weeks 1 14: Participants will receive vouchers for regular cocaine-free urine samples. Those who successfully complete this phase will continue to the next part of the study. * Weeks 13 27: Participants will receive either aripiprazole or placebo along with their methadone. During this part of the study, participants will keep electronic diaries to record cocaine use or craving and to record data on mood and activity. * Weeks 28 33: Participants will stop taking the aripipr
Interventions
- DRUG Placebo
- DRUG Airipiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2008-05-08 |
| Est. Completion | 2013-04-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00780702
The ClinicalTrials.gov registry entry for NCT00780702 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00780702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00780702 about?
NCT00780702 is a clinical study titled "Aripiprazole for Prevention of Relapse to Cocaine Use in Methadone-Maintenance Patients". Background: * The effectiveness of methadone maintenance for treatment of heroin addiction has been well established. However, patients maintained on methadone may relapse to cocaine use, even when they are enrolled in a comprehensive treatment program. Relapse has been attributed to several factor...
What is the current status of trial NCT00780702?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2008-05-08. Estimated completion is 2013-04-16.
What interventions are being tested in trial NCT00780702?
The interventions under investigation include: Placebo (DRUG), Airipiprazole (DRUG).
Who is sponsoring clinical trial NCT00780702?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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