Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

High rates of ADHD have been reported in adolescents with SUD. In addition, untreated ADHD
is a risk factor for developing SUD. Atomoxetine is a norepinephrine reuptake inhibitor,
and is currently used to treat adolescents with ADHD. The purpose of this trial is to
evaluate the efficacy of atomoxetine in treating adolescents dually diagnosed with ADHD and
SUD.

This study will last up to 18 weeks. Participants will receive six treatments of
manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks.
Participants and their parents will partake in therapy sessions. Subjects who have
completed at least 2 weeks of CBT will be eligible to enter the controlled trial, at which
point participants will be randomly assigned to receive either atomoxetine or placebo, which
they will take once daily for 12 weeks. At the Week 12 study visit, participants will be
assessed for symptoms of ADHD and SUD.

Inclusion Criteria:

- DSM-IV diagnosis of ADHD

- Current or recent (within the three months prior to study entry) SUD, including
marijuana and alcohol abuse

- ADHD CGI-S score of greater to or equal to 4

Exclusion Criteria:

- Any Unstable medical condition

- Recent history of intravenous drug use or cocaine dependence

- Currently abusing ecstasy, cocaine, gamma-hydroxybutyrate, methamphetamine,
amphetamine, opioids, phencyclidine, or benzodiazepine

- Mental retardation or organic brain syndrome

- Currently psychotic or history of bipolar disorder

- Currently taking any psychotropic or anti-substance abuse disorder medications

- Current DSM-IV diagnosis of major depression, depressive disorder, or anorexia

- Pregnant or breastfeeding