Randomized, double blind, placebo-controlled trial of disulfiram for the treatment of cocaine dependence in methadone-stabilized patients.

Abstract

UNLABELLED:

This study examined the dose-related efficacy of disulfiram for treating cocaine dependence in methadone-stabilized cocaine dependent participants.

DESIGN:

One hundred and sixty-one cocaine- and opioid-dependent volunteers were entered into a 14-week, double blind, randomized, placebo-controlled clinical trial at two sites.

METHODS:

Participants were stabilized on methadone during weeks 1-2 and received disulfiram at 0, 62.5, 125 or 250 mg/day during weeks 3-14. All participants also received weekly cognitive behavioral therapy. Thrice-weekly urine samples and weekly self-reported drug use assessments were obtained.

RESULTS:

Baseline subject characteristics, retention and drug use did not differ across groups. Outcome analyses were performed on those who participated beyond week 2. Opioid-positive urine samples and self-reported opioid use did not differ by treatment group. The prevalence of alcohol use was low prior to and during the trial and did not differ by treatment group. Cocaine-positive urines increased over time in the 62.5 and 125 mg disulfiram groups and decreased over time in the 250 mg disulfiram and placebo groups (p < 0.0001). Self-reported cocaine use increased in the 125 mg disulfiram group relative to the other three treatment groups (p = 0.04).

CONCLUSIONS:

Disulfiram may be contraindicated for cocaine dependence at doses <250 mg/day. Whether disulfiram at higher doses is efficacious in reducing cocaine use in dually cocaine and opioid dependent individuals needs to be determined.

• Authors: Alison Oliveto, James Poling, Michael J Mancino, Zachary Feldman, Joseph F Cubells, Rhonda Pruzinsky, Kishorchandra Gonsai, Christopher Cargile, Mehmet Sofuoglu, Mohit P Chopra, Gerardo Gonzalez-Haddad, Kathleen M Carroll, Thomas R Kosten
• Journal: Drug and alcohol dependence (Drug Alcohol Depend) Vol. 113 Issue 2-3 Pg. 184-91 (Jan 15 2011) ISSN: 1879-0046 [Electronic] Ireland
• PMID: 20828943 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Cocaine
• Disulfiram
• Methadone

Topics

• Adult
• Alcohol Drinking (epidemiology)
• Cocaine (urine)
• Cocaine-Related Disorders (drug therapy, therapy, urine)
• Cognitive Behavioral Therapy
• Disulfiram (therapeutic use)
• Dose-Response Relationship, Drug
• Female
• Humans
• Male
• Methadone (therapeutic use)
• Opiate Substitution Treatment (methods)
• Opioid-Related Disorders (drug therapy, therapy, urine)
• Self Report