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

Denver Health and Hospital Authority

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder; Substance Abuse

Treatments: Drug: Atomoxetine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00399763

05-0563

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo plus individual cognitive behavioral therapy

Treatment:

Drug: Placebo

2

Experimental group

Description:

atomoxetine plus individual cognitive behavioral therapy

Treatment:

Drug: Atomoxetine