Study Suggests Strattera(R) Improved ADHD Symptoms In Patients With Comorbid Alcohol Abuse

Data from a recent clinical study showed Strattera(R) (atomoxetine HCl) improved symptoms of Attention- Deficit/Hyperactivity Disorder (ADHD) in patients with comorbid alcohol abuse disorder, suggesting ADHD can be treated safely and effectively with Strattera in patients with both disorders. Results from the 12-week study were presented today at a major medical meeting of psychiatrists.

The study was designed to test the hypothesis that Strattera is superior to placebo in the treatment of ADHD symptoms and prevention of relapse of alcohol abuse in adult patients with both ADHD and comorbid alcohol abuse disorder who were recently abstinent.

“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, M.D., 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.”

Results of the study of 147 adults who met full DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD and comorbid alcohol abuse, showed that Strattera was superior to placebo in the reduction of ADHD symptoms as measured by the ADHD Investigator Symptom Rating Scale (AISRS). At study endpoint of 12 weeks the reduction of ADHD symptoms in subjects with comorbid alcohol abuse disorder was significantly improved for the Strattera group (-13.63) relative to the placebo group (-8.31). The study showed no significant difference in time to alcohol abuse relapse between the Strattera and placebo treatment 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 to placebo, though more study is needed to determine the validity of this specific finding.

ADHD is a potential risk factor for developing alcohol abuse problems.(1) In addition, alcohol abuse problems may be more common among people with ADHD than among those without ADHD. According to data from the National Comorbidity Survey Replication, nearly three times the number of individuals with ADHD (12 percent) have comorbid alcohol abuse or dependence disorder compared to the general population (4.4 percent).(2)

Strattera was generally well-tolerated in this study. Adverse events were similar to those noted in previous trials and discontinuations due to adverse events were not different between groups. The most common adverse events reported were nausea, dry mouth, decreased appetite, dizziness, fatigue, constipation and urinary hesitation. Discontinuation rates reported in this study from adverse events were 9.7 percent for the Strattera group compared to 2.7 percent for the placebo group.

Methods

In this randomized, placebo-controlled study, 72 patients received Strattera (25-100 mg daily) and 75 patients received placebo for approximately 12 weeks, at which time, their ADHD symptoms were measured using the AISRS. Study subjects were recently abstinent from alcohol at least four days before study randomization and included 125 men and 22 women, mean age approximately 34 years-old.

The study design allowed investigators to evaluate whether Strattera is superior to placebo in the treatment of ADHD symptoms and effective in preventing alcohol abuse relapse in adults with ADHD and comorbid alcohol abuse disorder. Time to relapse was defined as four standard alcoholic drinks for females or five standard alcoholic drinks for males 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.