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

A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder; Substance Abuse
• Intervention / Treatment: Drug: Placebo; Drug: Atomoxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; placebo plus individual cognitive behavioral therapy	Drug: Placebo; Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
Experimental: 2; atomoxetine plus individual cognitive behavioral therapy	Drug: Atomoxetine; Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder; Other Names: Strattera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist	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.	baseline and weekly through week 12 post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Line Followback Interview (TLFB)	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.	12 weeks
Side Effect Form for Children and Adolescents (SEFCA)	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.	weekly from randomization to 12 weeks post-randomization

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: American Academy of Child Adolescent Psychiatry.
• Investigators: Principal Investigator: Christian C Thurstone, MD, Denver Health

Publications and helpful links

General Publications

• Thurstone C, Riggs PD, Salomonsen-Sautel S, Mikulich-Gilbertson SK. Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):573-82. doi: 10.1016/j.jaac.2010.02.013.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: November 13, 2006
• First Submitted That Met QC Criteria: November 14, 2006
• First Posted (Estimate): November 15, 2006

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: June 12, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Adolescent; ADHD; SUD
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Substance-Related Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 05-0563