N/A N=70 Randomized Double-blind Treatment

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

Attention Deficit Hyperactivity Disorder · Substance Abuse

Bottom Line

View on ClinicalTrials.gov: NCT00399763 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Jul 2015

Primary outcome: Primary: Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist — 18.61; 18.19 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Atomoxetine (Drug); Placebo (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: Denver Health and Hospital Authority
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist	18.61; 18.19	—
SECONDARY Time Line Followback Interview (TLFB)	-2.24; -5.78	—
SECONDARY Side Effect Form for Children and Adolescents (SEFCA)	1; 1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00399763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.