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

This study has been completed.
Sponsor:
Collaborator:
American Academy of Child Adolescent Psychiatry.
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00399763
First received: November 13, 2006
Last updated: June 12, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Substance Abuse
Drug: Atomoxetine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time Line Followback Interview (TLFB) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 70
Study Start Date: September 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Strattera

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

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399763

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
American Academy of Child Adolescent Psychiatry.
Investigators
Principal Investigator: Christian C Thurstone, MD Denver Health
  More Information

No publications provided by Denver Health and Hospital Authority

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00399763     History of Changes
Other Study ID Numbers: 05-0563
Study First Received: November 13, 2006
Results First Received: August 3, 2012
Last Updated: June 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
Adolescent
ADHD
SUD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Substance-Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Chemically-Induced Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 02, 2015