Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling

Background: The authors' goal was to assess the efficacy and tolerability of naltrexone in the treatment of pathologic gambling disorder. Methods: Eighty-three subjects who met criteria for DSM-IV pathologic gambling disorder were enrolled in a I-week single-blind placebo lend-in followed by an 11-week double-blind naltrexone or placebo trial. Naltrexone was started at 25 mg/day and titrated upward until maximum symptom improvement or 250 mg/day was achieved Gambling symptom change was assessed with the patient-rated Clinical Global Impression (PG-CGI-PT), clinician-rated CGI (PG-CGI-MD), and the Gambling Symptom Rating Scale (G-SAS). Side effects were monitored weekly and liver function tests biweekly. Results: Data from 45 patients were analyzed Using random regression analysis, significant improvement was noted in all three gambling symptom measures: patient-rated Clinical Global Impression, p < .001; clinician-rated CGI, p < .001; Gambling Symptom Rating Scale, p < .019. At study end, 75% of subjects taking naltrexone were much or very much improved on both the PE-CEI PT and the PG-CGI-MD, compared with only 24% of those on placebo. Elevated liver enzymes occurred in four subjects who were taking analgesics concurrently. Nausea was common during the first week of treatment. Conclusions: Results suggest that naltrexone is effective in reducing the symptoms of pathologic gambling. Until further studies corroborate the present findings, our report should be interpreted cautiously. (C) 2001 Society of Biological Psychiatry.