Atomoxetine treatment of adults with ADHD and comorbid alcohol abuse disorder

Objective: Adults with ADHD have higher rates of alcohol use disorders (AUD) than controls. This study tested the hypothesis that atomoxetine (Atmx)is superior to placebo in the treatment of ADHD and alcohol use in recently abstinent adult subjects with ADHD and comorbid AUD. Methods: Subjects were adults who met DSM-IV-TR criteria for both ADHD and AUD and were abstinent from alcohol 4–30d before study entry. Participants received Atmx (25–100mg/d)or placebo for 12 wks. Standard measurements for ADHD and AUD were used. Time to relapse of alcohol abuse was analyzed using a 2-sided log-rank test based on Kaplan-Meier estimates. Cumulative heavy drinking events over time were evaluated post hoc with a recurrent event analysis. Results: A total of 147 subjects received Atmx (n=72) or placebo (n=75),80 completed the 12 wk double-blind period (n=32 and 48). ADHD symptoms were improved in the Atmx cohort vs. placebo (P=.007). Time to relapse showed no significant differences between treatment arms; however recurrent event analysis showed that Atmx reduced the cumulative number of heavy drinking episodes by approx. 26% compared to placebo (P=.023). There were no serious adverse events or specific drug-drug reactions related to current alcohol use. Conclusions: This controlled study of adult ADHD subjects in very recent remission from AUD demonstrates robust effects in improving ADHD and suggests an effect of atomoxetine reducing cumulative heavy drinking events over time.