A double blind, placebo-controlled trial that combines disulfiram and naltrexone for treating co-occurring cocaine and alcohol dependence.
BACKGROUND
This is a double blind, placebo-controlled trial that evaluated the efficacy of disulfiram, naltrexone and their combination in patients with co-occurring cocaine and alcohol dependence.


METHODS
208 patients were randomized to disulfiram (250 mg/day), naltrexone (100 mg/day), the combination, or placebo for 11 weeks. Outcomes were in-trial abstinence from cocaine and/or alcohol.


RESULTS
Few safety concerns were reported, although medication adherence was low in a number of patients for both medications, alone or in combination. In the primary analyses (GEE modeling), abstinence from cocaine as measured by cocaine-negative urines and days of self-reported abstinence from cocaine or alcohol did not differ between placebo and any of the medication groups. However, patients taking disulfiram (alone or in combination) were most likely to achieve combined abstinence from cocaine and alcohol. Secondary analyses revealed that patients taking the disulfiram-naltrexone combination were most likely to achieve 3 consecutive weeks of abstinence from cocaine and alcohol.


CONCLUSIONS
There was an association between disulfiram treatment and abstinence from cocaine and alcohol. More patients taking the disulfiram-naltrexone combination achieved 3 consecutive weeks of abstinence in treatment than placebo-treated patients.
Pettinati
Helen M
HM
Center for the Study of Addictions, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. pettinati_h@mail.trc.upenn.edu <pettinati_h@mail.trc.upenn.edu>
Kampman
Kyle M
KM
Lynch
Kevin G
KG
Xie
Hu
H
Dackis
Charles
C
Rabinowitz
Amanda R
AR
O'Brien
Charles P
CP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000427:Alcohol Deterrents / Q000627:therapeutic use*; D000437:Alcoholism / Q000188:drug therapy*; D019970:Cocaine-Related Disorders / Q000188:drug therapy*; D004221:Disulfiram / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D016896:Treatment Outcome
D000427:Alcohol Deterrents; D009292:Narcotic Antagonists; D009271:Naltrexone; D004221:Disulfiram