Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder - Full Text View

Sponsors and Collaborators:	Denver Health and Hospital Authority American Academy of Child Adolescent Psychiatry.
Information provided by:	Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT00399763

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

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)

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
1: Placebo Comparator placebo	Drug: Atomoxetine atomoxetine/placebo
2: Experimental atomoxetine	Drug: Atomoxetine atomoxetine/placebo

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

Responsible Party:	Denver Health ( Christian Thurstone )
Study ID Numbers:	05-0563
Study First Received:	November 13, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00399763 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:

Adolescent
ADHD
SUD

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Disorders of Environmental Origin
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine
Dyskinesias
Signs and Symptoms

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Hyperkinesis
Neurologic Manifestations

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Atomoxetine
Disorders of Environmental Origin
Attention Deficit and Disruptive Behavior Disorders

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 07, 2009