Open-Label Disulfiram for Methamphetamine Dependence - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Arkansas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00731133

Purpose

This 8 week, open-label pilot clinical trial will examine the safety and tolerability of disulfiram at 250 mg/day in up to twelve 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.

Condition	Intervention	Phase
Methamphetamine Dependence	Drug: Disulfiram	Phase I Phase II

MedlinePlus related topics: Methamphetamine Urine and Urination

Drug Information available for: Disulfiram Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	Open-Label Pilot Study of Disulfiram for Methamphetamine Dependence

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Retention [ Time Frame: daily ] [ Designated as safety issue: No ]
Side Effects Ratings [ Time Frame: Thrice weekly ] [ Designated as safety issue: Yes ]
Drug Use - Urine Toxicology Screens [ Time Frame: Thrice Weekly ] [ Designated as safety issue: No ]

Secondary 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 ]

Estimated Enrollment:	12
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Disulfiram Disulfiram at 250 mg daily	Drug: Disulfiram 250 mg/day

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 twelve 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731133

Contacts

Contact: Amy Glenn

(501) 526-7969

ALGlenn@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alison Oliveto, Ph.D. 501-686-8969 aoliveto@uams.edu
Principal Investigator: Alison Oliveto, Ph.D.

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Arkansas

More Information

Responsible Party:	University of Arkansas for Medical Sciences ( Alison Oliveto, Ph.D./Principal Investigator )
Study ID Numbers:	5-P50-DA018197-105242, 5-P50-DA018197
Study First Received:	August 6, 2008
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00731133
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

disulfiram
methamphetamine dependence
open label

Study placed in the following topic categories:

Disulfiram
Methamphetamine
Dopamine
Amphetamine
Ethanol

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Enzyme Inhibitors

Central Nervous System Stimulants
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 16, 2009