Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
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|ClinicalTrials.gov Identifier: NCT00218322|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity Substance-Related Disorders||Drug: Atomoxetine hydrochloride Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||April 2006|
Placebo Comparator: 1
Treatment with placebo or atomoxetine for 12 weeks.
Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
Drug: Atomoxetine hydrochloride
Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
- Symptoms of ADHD and SUD (measured at Week 12) [ Time Frame: 12 Weeks (LOCF) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218322
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Timothy E. Wilens||Massachusetts General Hospital|