Naltrexone and disulfiram in patients with alcohol dependence and comorbid psychiatric disorders.
BACKGROUND
Disulfiram and naltrexone are approved by the Food and Drug Administration (FDA) for the treatment of alcoholism, but these agents have not been rigorously evaluated in dually diagnosed individuals.


METHODS
Two-hundred and fifty-four patients with an Axis I psychiatric disorder and comorbid alcohol dependence were treated for 12 weeks in an outpatient medication study conducted at three Veterans Administration outpatient clinics. Randomization included assignment to one of four groups: 1) naltrexone alone; 2) placebo alone; 3) (open-label) disulfiram and (blinded) naltrexone; or 4) (open-label) disulfiram and (blinded) placebo. Medication compliance was evaluated using the Microelectric Events Monitoring System. Primary outcomes were measures of alcohol use. Secondary outcomes included psychiatric symptoms, alcohol craving, g-GGT levels and adverse events.


RESULTS
There was a high rate of abstinence across groups. Subjects treated with an active medication had significantly more consecutive weeks of abstinence and less craving than those treated with placebo, but there were no significant group differences in other measures of alcohol consumption. There was no advantage of the combination of both medications.


CONCLUSIONS
These data suggest a modest advantage for the use of disulfiram and naltrexone for this group of dually diagnosed alcohol-dependent individuals but did not suggest an advantage in the combination.
Petrakis
Ismene L
IL
Department of Psychiatry, Yale University, New Haven, Connecticut 06516, USA. ismene.petrakis@yale.edu
Poling
James
J
Levinson
Carolyn
C
Nich
Charla
C
Carroll
Kathleen
K
Rounsaville
Bruce
B
D000427:Alcohol Deterrents / Q000009:adverse effects / Q000627:therapeutic use*; D000437:Alcoholism / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D017831:Diagnosis, Dual (Psychiatry); D004221:Disulfiram / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D000427:Alcohol Deterrents; D009292:Narcotic Antagonists; D009271:Naltrexone; D004221:Disulfiram