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NCT00295308 · ClinicalTrials.gov registry record · Phase 1
Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 208
- Enrollment target
NCT00295308 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 208 participants.
The verdict
NCT00295308, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 208 participants
- Enrollment target
Study Summary
Background: * Though the drug buprenorphine effectively treats dependence on opioids like heroin, some abstinent patients relapse to use during treatment. This relapse may be triggered by stress or stressful situations, and buprenorphine probably has no specific protective effect in these situations. Buprenorphine probably also has no specific effect on relapse to cocaine use. * Research has shown that clonidine, a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse to heroin and cocaine seeking in rats. Researchers are interested in studying whether a combination of clonidine and buprenorphine may be more effective in preventing drug relapse than administering one of the medications alone. Objectives: \- To determine whether clonidine, given to abstinent patients maintained on buprenorphine, is more effective than placebo in preventing relapse to heroin or cocaine use. Eligibility: \- Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking treatment. Design: * The study will last up to 36 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 buprenorphine over the first 14 days of the study. * Weeks 1 8: Participants will receive vouchers for regular substance-free urine samples. Those who successfully complete this phase will continue to the next part of the study. * Weeks 7 9: Participants will receive either clonidine or placebo along with the buprenorphine. The dose of clonidine will be stabilized during this time. * Weeks 9 22: Participants will continue to receive either clonidine or placebo along w
Interventions
- DRUG Placebo
- DRUG Clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2005-11-08 |
| Est. Completion | 2014-07-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00295308
The ClinicalTrials.gov registry entry for NCT00295308 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 208 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.
NCT00295308 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00295308 about?
NCT00295308 is a clinical study titled "Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients". Background: * Though the drug buprenorphine effectively treats dependence on opioids like heroin, some abstinent patients relapse to use during treatment. This relapse may be triggered by stress or stressful situations, and buprenorphine probably has no specific protective effect in these situation...
What is the current status of trial NCT00295308?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2005-11-08. Estimated completion is 2014-07-30.
What interventions are being tested in trial NCT00295308?
The interventions under investigation include: Placebo (DRUG), Clonidine (DRUG).
Who is sponsoring clinical trial NCT00295308?
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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