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

NCT ID: NCT00029614

Last Updated: 2010-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Substance Use Disorders Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atomoxetine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Principal Investigators

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Oscar G. Bukstein, MD

Role: PRINCIPAL_INVESTIGATOR

Western Psychiatric Institute and Clinic

Locations

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Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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K24AA000301

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant 5K24AA000301-05

Identifier Type: -

Identifier Source: secondary_id

NIAAABUK00301

Identifier Type: -

Identifier Source: org_study_id

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