Open-Label Disulfiram for Methamphetamine Dependence
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
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.