Open-Label Disulfiram for Methamphetamine Dependence

NCT00731133 | Completed Phase 1 Results DMC

• 3 other identifiers: 5-P50-DA018197-1052425P50DA018197DPMCDA
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence

Keywords

disulfiram; methamphetamine dependence; open label

Outcome Measures

Primary Outcomes (1)

• Side Effects Checklist

  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.

  Weekly for six weeks

Secondary Outcomes (1)

• Proportion of Amphetamine-positive Urine Samples

  thrice weekly for 6 weeks

Study Arms (1)

Disulfiram

OTHER

Disulfiram at 250 mg daily

Drug: Disulfiram

Interventions

Disulfiram DRUG

250 mg/day

Also known as: Antabuse

Disulfiram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Disulfiram

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Limitations and Caveats

Large dropout so few participants had data throughout the trial. No control group so cannot determine whether side effects were related to disulfiram or an artifact of participation.

Results Point of Contact

• Title: Dr. Alison Oliveto
• Organization: UAMS

olivetoalison@uams.edu

501-526-8441

Study Officials

• Alison Oliveto, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 27, 2012
• Results First Posted: February 27, 2012

Record last verified: 2012-01

Locations

US (1)