Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder.
OBJECTIVE
To evaluate the effect of atomoxetine hydrochloride versus placebo on attention-deficit/hyperactivity disorder (ADHD) and substance use disorder (SUD) in adolescents receiving motivational interviewing/cognitive behavioral therapy (MI/CBT) for SUD.


METHODS
This single-site, randomized, controlled trial was conducted between December 2005 and February 2008. Seventy adolescents (13 through 19 years of age) with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) ADHD, a DSM-IV ADHD checklist score greater than or equal to 22, and at least one nontobacco SUD were recruited from the community. All subjects received 12 weeks of atomoxetine hydrochloride + MI/CBT versus placebo + MI/CBT. The main outcome measure for ADHD was self-report DSM-IV ADHD checklist score. For SUD, the main outcome was self-report number of days used nontobacco substances in the past 28 days using the Timeline Followback interview.


RESULTS
Change in ADHD scores did not differ between atomoxetine + MI/CBT and placebo + MI/CBT (F4,191 = 1.23, p = .2975). Change in days used nonnicotine substances in the last 28 days did not differ between groups (F3,100 = 2.06, p = .1103).


CONCLUSIONS
There was no significant difference between the atomoxetine + MI/CBT and placebo + MI/CBT groups in ADHD or substance use change. The MI/CBT and/or a placebo effect may have contributed to a large treatment response in the placebo group. Clinical Trials Registry Information-A Randomized, Placebo-Controlled Trial of Atomoxetine for Attention-Deficit/Hyperactivity Disorder in Adolescents with Substance Use Disorder. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00399763.
Thurstone
Christian
C
Denver Health and Hospital Authority, Behavioral Health Services, and the University of Colorado Denver, 80238, USA. Christian.Thurstone@dhha.org
Riggs
Paula D
PD
Salomonsen-Sautel
Stacy
S
Mikulich-Gilbertson
Susan K
SK
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000523:psychology / Q000534:rehabilitation*; D057189:Checklist; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D015897:Comorbidity; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007406:Interview, Psychological; D008297:Male; D009042:Motivation; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*; D019966:Substance-Related Disorders / Q000523:psychology / Q000534:rehabilitation*
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride