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Open-Label Disulfiram for Methamphetamine Dependence

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ClinicalTrials.gov Identifier: NCT00731133
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE August 6, 2008
First Posted Date  ICMJE August 8, 2008
Results First Submitted Date  ICMJE November 2, 2011
Results First Posted Date  ICMJE February 27, 2012
Last Update Posted Date February 27, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2008)
  • Retention [ Time Frame: daily ]
  • Side Effects Ratings [ Time Frame: Thrice weekly ]
  • Drug Use - Urine Toxicology Screens [ Time Frame: Thrice Weekly ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2008)
  • Blood Pressure [ Time Frame: thrice weekly ]
  • Self-reported drug use [ Time Frame: weekly ]
  • Self-reported mood (depression and anxiety ratings) [ Time Frame: weekly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Disulfiram for Methamphetamine Dependence
Official Title  ICMJE Open-Label Pilot Study of Disulfiram for Methamphetamine Dependence
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 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Methamphetamine Dependence
Intervention  ICMJE Drug: Disulfiram
250 mg/day
Other Name: Antabuse
Study Arms  ICMJE Disulfiram
Disulfiram at 250 mg daily
Intervention: Drug: Disulfiram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2012)
15
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2008)
12
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00731133
Other Study ID Numbers  ICMJE 5-P50-DA018197-105242
5P50DA018197 ( U.S. NIH Grant/Contract )
DPMCDA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alison Oliveto, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP