Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD

Study Overview
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Brief Summary
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The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing SUD relapse.

Official Title
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Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)

Conditions
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Attention Deficit Hyperactivity Disorder, Substance Use Disorder

Intervention / Treatment
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* Drug: Atomoxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female outpatients 15-30 years. Subjects with a DSM-IV diagnosis of ADHD (combined or inattentive subtype) as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician. Subjects with a current or recent (within three months) substance use disorder (drugs or alcohol) as determined through clinical evaluation and/or ascertained through structured diagnostic interview. Subjects with an ADHD CGI-S of >= 4 (moderate impairment). Exclusion Criteria: Pregnant or nursing females. Subjects with a clinically unstable medical condition that will either jeopardize patient safety or affect the scientific merit of the study, or who undergo a change in treatment during the study. Recent history of intravenous drug use, or subjects who have current DSM-IV criteria for abuse or dependence of cocaine, MDA, MDMA, gammahydroxybutyrate, methamphetamines, amphetamines, opioids, PCP, or benzodiazepines that in the opinion of the investigator will interfere in their ability to participate safely in the study. Subjects with Mental Retardation or Organic Brain Syndromes. Subjects who are psychotic or have a history of bipolar disorder. Participants who are taking any psychotropic or anti-SUD medications will be excluded from the study. Current DSM-IV diagnosis of major depression, depressive disorders, or anorexia as manifested by clinical interviews.

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 |
| --- | --- |
| Active Comparator: Atomoxetine<br> | Drug: Atomoxetine<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |