Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-02-29

Brief Summary

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The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems.

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Detailed Description

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Evidence-based psychosocial treatments have recently been developed. However, very little data exist on the use of pharmacotherapy for adolescents SUD (Substance Use Disorder). One promising pharmacotherapy approach is to treat co-occuring psychiatric disorders. A common co-occurring disorder in adolescent SUD is attention-deficit/hyperactivity disorder (ADHD). Fortunately, new ADHD medications, such as atomoxetine, that do not have addictive potential are now available. However, all controlled studies of atomoxetine have specifically excluded teens with SUD. Therefore, little data exist on the safety and efficacy of the medication in this population. This research project will address the important research gap with the specific aim: to conduct a randomized, placebo-controlled trial of atomoxetine for ADHD in teens with SUD.

Conditions

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Attention Deficit Hyperactivity Disorder Substance Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

placebo plus individual cognitive behavioral therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder

2

atomoxetine plus individual cognitive behavioral therapy

Group Type EXPERIMENTAL

Atomoxetine

Intervention Type DRUG

Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder

Interventions

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Atomoxetine

Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder

Intervention Type DRUG

Placebo

Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder

Intervention Type DRUG

Other Intervention Names

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Strattera

Eligibility Criteria

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Inclusion Criteria

* Age 12-19
* Provided assent/consent
* attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
* Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist \<=22
* At least one non-nicotine substance use disorder (SUD) by KSADS
* Plans to live locally for 4 months
* Willing to participate in cognitive behavioral therapy (CBT)

Exclusion Criteria

* No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
* No allergy to atomoxetine
* No narrow angle glaucoma
* No serious medical illness
* Not pregnant
* Not unwilling to use an effective form of contraception during the trial
* No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication

Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes