CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Disulfiramdrug
Likely dose
Disulfiram 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00731133
NCT00731133Phase 2Completed

Open-Label Pilot Study of Disulfiram for Methamphetamine Dependence

University of Arkansas·interventional·Posted Aug 8, 2008·Updated Feb 27, 2012

In Brief

A Phase 2 clinical trial evaluating Disulfiram for Methamphetamine Dependence. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2008
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.9 years ago

Interventions

Disulfiramdrug

250 mg/day