Status:
COMPLETED
Open-Label Disulfiram for Methamphetamine Dependence
Lead Sponsor:
University of Arkansas
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 pro...
Detailed Description
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 pro...
Eligibility Criteria
Inclusion
- 18-65 years old
- not currently enrolled in a treatment program
- subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
- subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
- women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.
Exclusion
- current diagnosis of alcohol physical dependence
- significant medical conditions such as abnormal liver function (e.g., laboratory findings on ALT or AST greater than three times normal), active hepatitis, uncontrolled hypertension, a current cardiac condition or high risk of cardiovascular disease (see section c.1), seizure disorders, or another significant underlying medical condition which would contraindicate disulfiram treatment
- meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders
- exhibiting current suicidality or homicidality
- pregnancy or breastfeeding
- current use of a prescribed psychotropic medication (e.g., antidepressants, anxiolytics, antipsychotics, anticonvulsants, etc.) which cannot be discontinued
- current use of medications such as anticoagulants, isoniazid, metronidazole, clotrimazole, and paraldehyde
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00731133
Start Date
August 1 2008
End Date
September 1 2010
Last Update
February 27 2012
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205