Back to resultsAtomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD
Primary Purpose
Substance Use Disorders, Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring ADHD, Substance Use
Eligibility Criteria
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.
Sites / Locations
- Western Psychiatric Institute and Clinic
Outcomes
Primary Outcome Measures
decrease in ADHD symptoms
decrease in the quantity and frequency of alcohol and other substance use
Secondary Outcome Measures
Full Information
NCT ID
NCT00029614
First Posted
January 16, 2002
Last Updated
April 27, 2010
Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00029614
Brief Title
Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD
Official Title
Psychopharmacology of Adolescents With AUD and ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Substance Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Primary Outcome Measure Information:
Title
decrease in ADHD symptoms
Title
decrease in the quantity and frequency of alcohol and other substance use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar G. Bukstein, MD
Organizational Affiliation
Western Psychiatric Institute and Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD
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