- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00731133
Open-Label Disulfiram for Methamphetamine Dependence
January 20, 2012 updated by: University of Arkansas
Open-Label Pilot Study of 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 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 Overview
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 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.
Results of this study will provide initial safety and drug use data for grant applications proposing to examine the clinical efficacy of disulfiram or similar agents to for treating methamphetamine dependence under placebo-controlled, double-blind conditions.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Disulfiram
Disulfiram at 250 mg daily
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250 mg/day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side Effects Checklist
Time Frame: Weekly for six weeks
|
It consists of 25 items describing side effects specific to disulfiram alone or combined with alcohol or cocaine that are rated on a scale from 0 (not at all) to 4 (very much).
Total scores range from 0 (minimum) to 100 (maximum).
Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time.
A slope and standard deviation describing this change over time were generated and used as our outcome measures.
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Weekly for six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Amphetamine-positive Urine Samples
Time Frame: thrice weekly for 6 weeks
|
the proportion of urine samples positive for amphetamine.
Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time.
A slope and standard deviation describing this change over time were generated and used as our outcome measures.
|
thrice weekly for 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
August 6, 2008
First Submitted That Met QC Criteria
August 6, 2008
First Posted (Estimate)
August 8, 2008
Study Record Updates
Last Update Posted (Estimate)
February 27, 2012
Last Update Submitted That Met QC Criteria
January 20, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5-P50-DA018197-105242
- DPMCDA (Other Identifier: NIDA)
- 5P50DA018197 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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