Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218322
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 7, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Timothy Wilens, MD, 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Substance-Related Disorders Drug: Atomoxetine hydrochloride Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
Treatment with placebo or atomoxetine for 12 weeks.
Drug: Placebo
Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.

Experimental: 2 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.

Primary Outcome Measures :
  1. Symptoms of ADHD and SUD (measured at Week 12) [ Time Frame: 12 Weeks (LOCF) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00218322

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Timothy E. Wilens Massachusetts General Hospital

Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital Identifier: NCT00218322     History of Changes
Other Study ID Numbers: NIDA-16264-1
K24DA016264 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs