Post-treatment outcomes in a double-blind, randomized trial of sertraline for alcohol dependence

Abstract

Background: Pharmacotherapy studies in alcohol dependence (AD) are generally of short duration and do not include post-treatment follow-up. We examined the durability of treatment effects in a placebo-controlled trial of sertraline for AD.

Methods: As previously reported, patients received 12 weeks of treatment with sertraline (n = 63) or placebo (n = 71), followed by assessments at 3 and 6 months post-treatment (Kranzler et al., 2011, J Clin Psychopharmacol 31:22-30). We examined the main and interaction effects with time of 3 between-subject factors (medication group, age of onset of AD [late-onset alcoholics, LOAs, vs. early-onset alcoholics, EOAs], and the tri-allelic 5-HTTLPR genotype) on drinking days (DDs) and heavy drinking days (HDDs).

Results: The medication group effect, which was significant during treatment, remained significant during the 3-month follow-up period for L'/L' LOAs, with the sertraline group having fewer DDs than the placebo group (p = 0.027). However, the medication group effect seen in L'/L' EOAs during treatment was no longer significant (p = 0.48). There were no significant effects in S' carriers at the 3-month follow-up visit, or in either genotype group at the 6-month follow-up.

Conclusions: The beneficial effects of sertraline observed in LOAs during treatment persisted during the 3-month post-treatment period. Additional studies are needed to validate these pharmacogenetic findings, which together with the effects seen during active treatment support the use of sertraline only in LOAs.

Trial registration: ClinicalTrials.gov NCT00368550.