Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
First received: September 22, 2010
Last updated: March 4, 2013
Last verified: March 2013
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.
Attention Deficit Hyperactivity Disorder
Substance Use Disorder
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)
Active Comparator: Atomoxetine
Placebo Comparator: Placebo
|Ages Eligible for Study:
||15 Years to 30 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01207622
|Massachusetts General Hospital
|Cambridge, Massachusetts, United States, 02138 |
Massachusetts General Hospital
||Timothy Wilens, MD
||Massachusetts General Hospital
No publications provided
||Timothy Wilens, MD, MD, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 22, 2010
||March 4, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Attention Deficit Disorder with Hyperactivity
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs