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

April 27, 2010 updated by: University of Pittsburgh

Psychopharmacology of Adolescents With AUD and ADHD

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Atomoxetine

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - Western Psychiatric Institute and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
decrease in ADHD symptoms
decrease in the quantity and frequency of alcohol and other substance use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Oscar G. Bukstein, MD, Western Psychiatric Institute and Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

January 16, 2002

First Submitted That Met QC Criteria

January 16, 2002

First Posted (Estimate)

January 17, 2002

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NIAAABUK00301
K24AA000301 (U.S. NIH Grant/Contract)
NIH Grant 5K24AA000301-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.