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

This study has been completed.

First Received: January 16, 2002 Last Updated: November 28, 2007 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00029614

Purpose

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).

Condition	Intervention	Phase
Substance Use Disorders Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Psychopharmacology of Adolescents With AUD and ADHD

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	May 2006
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029614

Locations

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

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Oscar G. Bukstein, MD

Western Psychiatric Institute and Clinic

More Information

No publications provided

Study ID Numbers:	NIAAABUK00301, NIH Grant 5K24AA000301-05
Study First Received:	January 16, 2002
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00029614 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

ADHD
Substance Use

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Atomoxetine
Disorders of Environmental Origin
Attention Deficit and Disruptive Behavior Disorders

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on November 22, 2009