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

Overview

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.

Full Title of Study: “A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2008

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.

Interventions

  • Drug: Atomoxetine
    • Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
  • Drug: Placebo
    • Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder

Arms, Groups and Cohorts

  • Placebo Comparator: 1
    • placebo plus individual cognitive behavioral therapy
  • Experimental: 2
    • atomoxetine plus individual cognitive behavioral therapy

Clinical Trial Outcome Measures

Primary Measures

  • Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
    • Time Frame: baseline and weekly through week 12 post randomization
    • All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.

Secondary Measures

  • Time Line Followback Interview (TLFB)
    • Time Frame: 12 weeks
    • The TLFB assesses the number of days in which a substance was used in the past 28 days. The TLFB is administered by the clinician and uses a 28-day calendar with anchor points to record this information. This instrument relies on confidential self-report of the adolescent participant. The result is reported as mean change in the number of days used substances in the past 28 days from baseline to the end of treatment using linear mixed models in an intent-to-treat analysis.
  • Side Effect Form for Children and Adolescents (SEFCA)
    • Time Frame: weekly from randomization to 12 weeks post-randomization
    • The SEFCA is a clinician-administered instrument that systematically assesses 52 possible side effects and rates them on a scale of 0 (not present) to 3 (severe). The instrument relies on confidential, self-report of the adolescent.The number of serious adverse events was recorded by intervention assignment.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Denver Health and Hospital Authority
  • Collaborator
    • American Academy of Child Adolescent Psychiatry.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christian C Thurstone, MD, Principal Investigator, Denver Health

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