Atomoxetine to Treat Adolescents With Coexisting Alcohol... | NCT00029614

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

NCT00029614

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Apr 28, 2010Estimated

Enrollment

24Estimated

Phase

Phase 2

Conditions

Substance Use Disorders
Attention Deficit Hyperactivity Disorder

Interventions

Atomoxetine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K24AA000301	U.S. NIH Grant/Contract		View source
NIH Grant 5K24AA000301-05

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Jan 16, 2002

First Submission Date that Met QC Criteria

Jan 16, 2002

First Posted Date

Jan 17, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2010

Last Update Posted Date

Apr 28, 2010Estimated

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
decrease in ADHD symptoms
decrease in the quantity and frequency of alcohol and other substance use

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oscar G. Bukstein, MD	Western Psychiatric Institute and Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Psychiatric Institute and Clinic		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069445	Atomoxetine Hydrochloride

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided