Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Symptoms of ADHD and SUD (measured at Week 12)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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
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.
Investigators
Timothy Wilens, MD
MD
Massachusetts General Hospital
Eligibility Criteria
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
Arms & Interventions
1
Treatment with placebo or atomoxetine for 12 weeks.
Intervention: Placebo
2
Intervention: Atomoxetine hydrochloride
Outcomes
Primary Outcomes
Symptoms of ADHD and SUD (measured at Week 12)
Time Frame: 12 Weeks (LOCF)