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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

Page last updated: August 23, 2015

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