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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Psychopharmacology of Adolescents With AUD and ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029614
• Other study ID #: NIAAABUK00301
• Secondary ID: K24AA000301NIH G
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2002
• Last updated: April 27, 2010
• Start date: May 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• Atomoxetine

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in ADHD symptoms
Primary	decrease in the quantity and frequency of alcohol and other substance use