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

Condition(s) targeted: Attention Deficit Hyperactivity Disorder; Substance Use Disorder

Intervention: Atomoxetine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Denver Health and Hospital Authority

Official(s) and/or principal investigator(s):
Christian C Thurstone, MD, Principal Investigator, Affiliation: Denver Health

Overall contact:
Christian C Thurstone, MD, Phone: 303.436.6006, Email: christian.thurstone@dhha.org

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.

Official title: A Randomized, Placebo-Controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

DSM-IV checklist

Side Effect Form for Children and Adolescents

Secondary outcome:

Time Line Followback Interview

CBT Session Adherence

Marijuana craving

HIV risk

Ethics questionnaire

Detailed 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.

Minimum age: 12 Years. Maximum age: 19 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 12-19

- Provided assent/consent

- ADHD by KSADS

- DSM-IV checklist <=22

- At least one non-nicotine SUD by KSADS

- Plans to live locally for 4 months

- Willing to participate in 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

Christian C Thurstone, MD, Phone: 303.436.6006, Email: christian.thurstone@dhha.org

Denver Health Medical Center, Denver, Colorado 80204, United States; Recruiting
Christian C Thurstone, MD, Principal Investigator

Starting date: September 2005
Ending date: December 2007
Last updated: October 30, 2007