Open-Label Disulfiram for Methamphetamine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00731133
First received: August 6, 2008
Last updated: January 20, 2012
Last verified: January 2012

August 6, 2008
January 20, 2012
August 2008
September 2010   (final data collection date for primary outcome measure)
Side Effects Checklist [ Time Frame: Weekly for six weeks ] [ Designated as safety issue: Yes ]
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.
  • Side Effects Ratings [ Time Frame: Thrice weekly ] [ Designated as safety issue: Yes ]
  • Retention [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Drug Use - Urine Toxicology Screens [ Time Frame: Thrice Weekly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00731133 on ClinicalTrials.gov Archive Site
Proportion of Amphetamine-positive Urine Samples [ Time Frame: thrice weekly for 6 weeks ] [ Designated as safety issue: No ]
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.
  • Blood Pressure [ Time Frame: Thrice Weekly ] [ Designated as safety issue: Yes ]
  • Self-reported drug use [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • Self-reported mood (depression and anxiety ratings) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Open-Label Disulfiram for Methamphetamine Dependence
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Methamphetamine Dependence
Drug: Disulfiram
250 mg/day
Other Name: Antabuse
Disulfiram
Disulfiram at 250 mg daily
Intervention: Drug: Disulfiram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00731133
5-P50-DA018197-105242, 5-P50-DA018197, DPMCDA
Yes
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Alison Oliveto, PhD University of Arkansas
University of Arkansas
January 2012

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