Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With 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: NCT01207622
Recruitment Status : Withdrawn (Poor enrollment)
First Posted : September 23, 2010
Last Update Posted : March 5, 2013
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Substance Use Disorder Drug: Atomoxetine Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Atomoxetine Drug: Atomoxetine
Placebo Comparator: Placebo Drug: Placebo

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:

  • 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).

Exclusion Criteria:

  • 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.

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): NCT01207622

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Principal Investigator: Timothy Wilens, MD Massachusetts General Hospital

Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital Identifier: NCT01207622     History of Changes
Other Study ID Numbers: 2003-P-001823
5K24DA016264-02 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

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