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

November 13, 2006
October 2, 2008
September 2005
February 2008   (final data collection date for primary outcome measure)
DSM-IV checklist [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • DSM-IV checklist
  • Side Effect Form for Children and Adolescents
Complete list of historical versions of study NCT00399763 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time Line Followback Interview
  • CBT Session Adherence
  • Marijuana craving
  • HIV risk
  • Ethics questionnaire
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • Substance Abuse
Drug: Atomoxetine
atomoxetine/placebo
Other Name: Strattera
  • Placebo Comparator: 1
    placebo
    Intervention: Drug: Atomoxetine
  • Experimental: 2
    atomoxetine
    Intervention: Drug: Atomoxetine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
12 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00399763
05-0563
No
Christian Thurstone, Denver Health
Denver Health and Hospital Authority
American Academy of Child Adolescent Psychiatry.
Principal Investigator: Christian C Thurstone, MD Denver Health
Denver Health and Hospital Authority
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP