Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

Study Overview
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Brief Summary
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Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

Detailed Description
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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.

Official Title
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Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)

Conditions
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Attention Deficit Disorder With Hyperactivity, Substance-Related Disorders

Intervention / Treatment
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* Drug: Atomoxetine hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Treatment with placebo or atomoxetine for 12 weeks. | Drug: Placebo<br>* Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.<br>|
| Experimental: 2<br> | Drug: Atomoxetine hydrochloride<br>* Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of ADHD and SUD (measured at Week 12) |  | 12 Weeks (LOCF) |