Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
Information source: Denver Health and Hospital Authority
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder; Substance Abuse
Intervention: Atomoxetine (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Denver Health and Hospital Authority Official(s) and/or principal investigator(s): Christian C Thurstone, MD, Principal Investigator, Affiliation: Denver Health
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.
Clinical Details
Official title: A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
Secondary outcome: Time Line Followback Interview (TLFB)Side Effect Form for Children and Adolescents (SEFCA)
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
Minimum age: 12 Years.
Maximum age: 19 Years.
Gender(s): Both.
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
Locations and Contacts
Denver Health Medical Center, Denver, Colorado 80204, United States
Additional Information
Starting date: September 2005
Last updated: June 12, 2015
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