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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:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00399763
First received: November 13, 2006
Last updated: October 2, 2008
Last verified: October 2008
History of Changes
  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

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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • DSM-IV checklist [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time Line Followback Interview [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • CBT Session Adherence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Marijuana craving [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HIV risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Ethics questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Side Effect Form for Children and Adolescents [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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
 Drug: Atomoxetine
atomoxetine/placebo
Other Name: Strattera
Experimental: 2
atomoxetine
 Drug: Atomoxetine
atomoxetine/placebo
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
  • ADHD by KSADS
  • DSM-IV checklist <=22
  • At least one non-nicotine SUD by KSADS
  • Plans to live locally for 4 months
  • Willing to participate in 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
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: Christian Thurstone, Denver Health
ClinicalTrials.gov Identifier: NCT00399763     History of Changes
Other Study ID Numbers: 05-0563
Study First Received: November 13, 2006
Last Updated: October 2, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013