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Naltrexone plus sertraline more effective for abstinence than either alone

Clinical Question:
Is combination naltrexone and sertraline therapy for patients with alcohol dependence and deprerssion more effective than single drug therapy?

Bottom Line:
Patients with both depression and alcohol dependence are more likely to achieve abstinence when treated with both sertraline and naltrexone as compared with either medication alone or double placebo. (LOE = 1b)

Reference:
Pettinati HM, Oslin DW, Kampman KM, et al. A double-blind, placebo-controlled trial combining sertraline and naltrexone for treating co-occuring depression and alcohol dependence. Am J Psychiatry 2010;167(6):668-675.  [PMID:20231324]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Industry + govt

Allocation:
Concealed

Setting:
Outpatient (any)

Synopsis:
This randomized placebo-controlled trial included 170 patients aged 21 years to 75 years (mean age = 43 years) who had received DSM-IV diagnoses of both depression and alcohol dependence. They were randomized to receive sertraline 200 mg daily, naltrexone 100 mg daily, both, or double-placebo for 14 weeks. Dosing for both drugs was increased over time to the target doses. Inclusion criteria were consumption of at least 12 alcoholic drinks per week, consumption of alcohol on at least 40% of the 90 days prior to enrollment, 3 days of consecutive abstinence just before starting treatment, and Hamilton Depression Rating Scale (HAM-D) of at least 10 at the time of randomization. Patients were excluded if they had other drug dependencies, bipolar disorder, or psychotic illnesses; were taking other antidepressants or psychiatric medications; had severe medical illness; or were pregnant or breastfeeding. All study groups received cognitive-behavioral therapy. The abstinence rate during the 14-week treatment period in the combined therapy group was significantly higher than in the placebo group (53.7% vs 23.8% in the other 3 groups combined; P = .001; number needed to treat = 3; 95% CI, 2-8). There was no significant difference between the other groups regarding abstinence (21% for naltrexone alone, 28% for sertraline alone, and 23% for placebo). The differences between groups for remission of depression at the end of the study (defined as a HAM-D score of less than 10) was in the predicted direction, but did not reach statistical significance. Differences in adverse event rates and drop-outs also did nor reach statistical significance.

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