Atomoxetine can safely and effectively treat attention deficit hyperactivity disorder in adults with coexisting alcohol abuse disorder, according to a presentation at the annual meeting of the American Psychiatric Association.

The 12-week study was designed to test the hypothesis that atomoxetine is superior to placebo in the treatment of disorder symptoms and prevention of relapse of alcohol abuse in adult patients with both disorders who were recently abstinent.

"Attention deficit hyperactivity disorder (ADHD) is present in at least one-quarter of adults with alcohol abuse or dependence. Treating ADHD in adults with co-occurring alcohol abuse can be challenging, and up until now, no data have been available to help us know how to treat these patients. Often the first course of action is to treat the alcohol problem first, then later the ADHD," said study author Timothy E. Wilens, MD, director of substance abuse services in the Pediatric Psychopharmacology Clinics at Massachusetts General Hospital and associate professor of psychiatry at Harvard Medical School in Boston.

"While additional studies are needed, this study is encouraging because it is the first to show that ADHD can be treated safely and effectively with Strattera in patients with ADHD and very recent alcohol abuse."

The 147 adults met full DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD and comorbid alcohol abuse. Study subjects were recently abstinent from alcohol (at least four days before study randomization) and included 125 men and 22 women, mean age, 34 years.

The principal outcome measure was reduction of ADHD symptoms as measured by the ADHD Investigator Symptom Rating Scale (AISRS). A total of 72 patients were randomized to atomoxetine (25-100 mg daily), whereas 75 patients randomized to placebo.

At study endpoint of 12 weeks, reduction of symptoms in subjects with comorbid alcohol abuse disorder was significantly improved for atomoxetine (-13.63) compared with the placebo group (-8.31). There was no significant difference in time to alcohol abuse relapse between active treatment and placebo groups.

However, an exploratory post hoc analysis undertaken to examine drinking throughout the study suggested a positive trend in reducing cumulative heavy drinking days by 26 percent in the treated group compared with placebo. Additional ore study is needed to determine the validity of this specific finding.

Time to relapse was defined as four standard alcoholic drinks for women or five standard alcoholic drinks for men within 24 hours, or at least three standard alcoholic drinks per day for at least one week. A standard alcoholic drink was defined in this study as 12 ounces of regular beer, 5 ounces of wine or 1.5 ounces of 80-proof distilled spirits. Cumulative heavy drinking days were measured post hoc with a stratified Andersen-Gill recurrent-event Cox model.