Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder

Abstract

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.

Method: 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.

Conflict of interest statement

Disclosure: Drs. Thurstone, Riggs, and Mikulich-Gilbertson, and Ms. Salomonsen-Sautel report no biomedical financial interests or potential conflicts of interest.

2010 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Patient Disposition. Note: ADHD = Attention-Deficit/Hyperactivity Disorder; CBT = Cognitive Behavioral Therapy; SUD = Substance Use Disorder

Figure 2

Change in adolescent report DSM-IV ADHD score. Note: ADHD = Attention-Deficit/Hyperactivity Disorder; MI/CBT = motivational interviewing / cognitive behavioral therapy.

Figure 3

Change in number of days of non-nicotine substance use in the past 28 days. Note: MI/CBT = motivational interviewing / cognitive behavioral therapy.