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NCT00731133 · ClinicalTrials.gov registry record · Phase 1
Open-Label Disulfiram for Methamphetamine Dependence
A Phase 1 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00731133 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 15 participants.
The verdict
NCT00731133, a Phase 1 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This 8 week, open-label pilot clinical trial will examine the safety and tolerability of disulfiram at 250 mg/day in up to fifteen methamphetamine dependent individuals. After undergoing screening procedures (approximately one week), eligible subjects will enter the study proper attend clinic every weekday during week 1 of the trial in order to receive the disulfiram under observation and complete assessments. Then subjects will receive weekly blister packs of medication and attend clinic thrice weekly during weeks 2-6. During weeks 7-8, subjects no longer take disulfiram, are followed for two weeks, then referred to treatment elsewhere, if desired. Urine samples will be obtained and a disulfiram side-effects checklist will be completed thrice-weekly. Self-reported drug use, craving and mood ratings will be completed weekly. All subjects undergo cognitive behavioral therapy. Adjunctive contingency management procedures will be utilized to enhance retention. The primary outcomes of interest include retention, side-effects, and drug use. Our hypothesis is that disulfiram will be well tolerated in this population.
Interventions
- DRUG Disulfiram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-08 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00731133
The ClinicalTrials.gov registry entry for NCT00731133 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Disulfiram is the first listed.
NCT00731133 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00731133 about?
NCT00731133 is a clinical study titled "Open-Label Disulfiram for Methamphetamine Dependence". This 8 week, open-label pilot clinical trial will examine the safety and tolerability of disulfiram at 250 mg/day in up to fifteen methamphetamine dependent individuals. After undergoing screening procedures (approximately one week), eligible subjects will enter the study proper attend clinic every ...
What is the current status of trial NCT00731133?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2008-08. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00731133?
The interventions under investigation include: Disulfiram (DRUG).
Who is sponsoring clinical trial NCT00731133?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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