Randomized, double blind, placebo-controlled trial of disulfiram for the
treatment of cocaine dependence in methadone-stabilized patients.
Author(s): Oliveto A, Poling J, Mancino MJ, Feldman Z, Cubells JF, Pruzinsky R, Gonsai K,
Cargile C, Sofuoglu M, Chopra MP, Gonzalez-Haddad G, Carroll KM, Kosten TR.
Affiliation(s): Psychiatry Dept, University of Arkansas for Medical Sciences, Slot 843, 4301 W
Markham St, Little Rock, AR 72205, USA. olivetoalison@uams.edu
Publication date & source: 2011, Drug Alcohol Depend. , 113(2-3):184-91
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.
|