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

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

Tracking Information
First Submitted Date  ICMJE January 16, 2002
First Posted Date  ICMJE January 17, 2002
Last Update Posted Date April 28, 2010
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2006)
  • decrease in ADHD symptoms
  • decrease in the quantity and frequency of alcohol and other substance use
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00029614 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD
Official Title  ICMJE Psychopharmacology of Adolescents With AUD and ADHD
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance Use Disorders
  • Attention Deficit Hyperactivity Disorder
Intervention  ICMJE Drug: Atomoxetine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 26, 2006)
24
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
80
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00029614
Other Study ID Numbers  ICMJE NIAAABUK00301
K24AA000301 ( U.S. NIH Grant/Contract )
NIH Grant 5K24AA000301-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Oscar G. Bukstein, MD Western Psychiatric Institute and Clinic
PRS Account University of Pittsburgh
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP