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Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD

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: NCT00029614
Recruitment Status : Completed
First Posted : January 17, 2002
Last Update Posted : April 28, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
University of Pittsburgh

Brief Summary:
The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).

Condition or disease Intervention/treatment Phase
Substance Use Disorders Attention Deficit Hyperactivity Disorder Drug: Atomoxetine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychopharmacology of Adolescents With AUD and ADHD
Study Start Date : May 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. decrease in ADHD symptoms
  2. decrease in the quantity and frequency of alcohol and other substance use

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adolescents, ages 13-18
  • Meets criteria for alcohol and/or substance use disorder and attention deficit hyperactivity disorder.

Exclusion Criteria:

  • Adolescents who are pregnant.
  • Have a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk.
  • History of pervasive development disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders.
  • Currently on other psychotropic medications from which discontinuation would present a significant risk.
  • A current episode of major depressive disorder or a diagnosis of bipolar disorder.
  • Diagnosis of dependence for any substance other than marijuana.
  • Adolescents with a full-scale IQ below 80.

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): NCT00029614

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United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Oscar G. Bukstein, MD Western Psychiatric Institute and Clinic

Layout table for additonal information Identifier: NCT00029614     History of Changes
Other Study ID Numbers: NIAAABUK00301
K24AA000301 ( U.S. NIH Grant/Contract )
NIH Grant 5K24AA000301-05
First Posted: January 17, 2002    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: April 2010

Keywords provided by University of Pittsburgh:
Substance Use

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
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