Atomoxetine treatment of adults with ADHD and comorbid alcohol use disorders.
OBJECTIVE
Adults with attention-deficit/hyperactivity disorder (ADHD) have higher rates of alcohol and drug use disorders than adults without ADHD. The study aim was to determine if atomoxetine was superior to placebo in improving ADHD and alcohol use in recently abstinent adults with ADHD and comorbid alcohol use disorder.


METHODS
Adults with DSM-IV diagnoses of ADHD and alcohol abuse and/or dependence were abstinent from alcohol at least 4 days (maximum 30 days) before study randomization. Participants received atomoxetine (25-100mg daily) or placebo for 12 weeks. ADHD symptoms were assessed using ADHD Investigator Symptom Rating Scale (AISRS) total score. Time-to-relapse to heavy alcohol use was analyzed using a 2-sided log-rank test based on Kaplan-Meier estimates and cumulative heavy drinking events over time were evaluated post hoc with recurrent-event analysis.


RESULTS
Subjects received atomoxetine (n=72) or placebo (n=75) and 80 subjects completed the 12-week double-blind period (n=32 and 48, respectively). ADHD symptoms were significantly improved in the atomoxetine cohort compared to placebo (AISRS total score mean [S.D.], atomoxetine: -13.63 [11.35], P<.001; placebo: -8.31 [11.44], P<.001, difference: P=.007; effect size=0.48). No significant differences between treatment groups occurred in time-to-relapse of heavy drinking (P=.93). However, cumulative heavy drinking days were reduced 26% in atomoxetine-treated subjects versus placebo (event ratio=0.74, P=.023). There were no serious adverse events or specific drug-drug reactions related to current alcohol use.


CONCLUSIONS
This 3-month, double-blind, placebo-controlled study of atomoxetine in adults with ADHD and comorbid alcohol use disorder demonstrates clinically significant ADHD improvement, and inconsistent effects on drinking behavior.
Wilens
Timothy E
TE
Massachusetts General Hospital, 55 Fruit Street, YAW 6900, Boston, MA 02114, USA. twilens@partners.org <twilens@partners.org>
Adler
Lenard A
LA
Weiss
Margaret D
MD
Michelson
David
D
Ramsey
Janet L
JL
Moore
Rodney J
RJ
Renard
Didier
D
Brady
Kathleen T
KT
Trzepacz
Paula T
PT
Schuh
Leslie M
LM
Ahrbecker
Lisa M
LM
Levine
Louise R
LR
D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000328:Adult; D000428:Alcohol Drinking / Q000517:prevention & control / Q000523:psychology; D019973:Alcohol-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000453:epidemiology*; D015897:Comorbidity; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D011437:Propylamines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D010919:Placebos; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride