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

Phase 2

Completed

• Conditions: Substance Use Disorders; Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00029614
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-01-16
• Study First Submitted QC: 2002-01-16
• Study First Posted: 2002-01-17
• Study Start: 2006-05
• Study Completion: 2007-07
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-27
• Last Update Posted: 2010-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
decrease in ADHD symptoms
decrease in the quantity and frequency of alcohol and other substance use

Trial Locations

Locations (1)

Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States