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

November 13, 2006
June 12, 2015
September 2005
February 2008   (final data collection date for primary outcome measure)
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.
  • 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 (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.
  • 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
    Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
    Other Name: Strattera
  • Drug: Placebo
    Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
  • Placebo Comparator: 1
    placebo plus individual cognitive behavioral therapy
    Intervention: Drug: Placebo
  • Experimental: 2
    atomoxetine plus individual cognitive behavioral therapy
    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
  • 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
Both
12 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00399763
05-0563
No
Denver Health and Hospital Authority
Denver Health and Hospital Authority
American Academy of Child Adolescent Psychiatry.
Principal Investigator: Christian C Thurstone, MD Denver Health
Denver Health and Hospital Authority
June 2015

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