Clinical trial NCT00399763: Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
Official title: A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Substance Abuse
Keywords: Adolescent
ADHD
SUD
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: American Academy of Child Adolescent Psychiatry.
First posted: 2006-11-15
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
timeFrame: baseline and weekly through week 12 post randomization
Secondary outcomes:
measure: Time Line Followback Interview (TLFB)
timeFrame: 12 weeks
measure: Side Effect Form for Children and Adolescents (SEFCA)
timeFrame: weekly from randomization to 12 weeks post-randomization
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health
name: Christian C Thurstone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thurstone C, Riggs PD, Salomonsen-Sautel S, Mikulich-Gilbertson SK. Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):573-82. doi: 10.1016/j.jaac.2010.02.013.