N/A
Completed N=70
Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
Attention Deficit Hyperactivity Disorder · Substance Abuse
Source: ClinicalTrials.gov NCT00399763 ↗
Enrolled (actual)
70
Serious AEs
2.9%
Results posted
Jul 2015
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.