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Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)
This study is currently Recruiting
September 2009 By National Institute on Drug Abuse (NIDA)
First Recieved on September 16, 2005
Last Updated on September 2, 2009
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.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Treatment with placebo or atomoxetine for 12 weeks.
Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
|Ages Eligible for Study:||15 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- Investigator: Timothy E. Wilens - Principal Investigator - Massachusetts General Hospital