Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

Phase 4

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity; Substance-Related Disorders
• Interventions: Drug: Placebo; Drug: Atomoxetine hydrochloride

• Registration Number: NCT00218322
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2006-03
• Study Completion: 2006-04
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-06
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Treatment with placebo or atomoxetine for 12 weeks.
2	Atomoxetine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Symptoms of ADHD and SUD (measured at Week 12)	12 Weeks (LOCF)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States