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

Tracking Information

First Received Date ^ICMJE

January 16, 2002

Last Updated Date

November 28, 2007

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00029614 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Substance Use Disorders
Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

Drug: Atomoxetine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

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.

Gender

Both

Ages

13 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00029614

Responsible Party

Study ID Numbers ^ICMJE

NIAAABUK00301, NIH Grant 5K24AA000301-05

Study Sponsor ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Oscar G. Bukstein, MD

Western Psychiatric Institute and Clinic

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

November 2007

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