Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • atomoxetine/placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • placebo
• Experimental: 2
  • atomoxetine

Primary Measures

• DSM-IV checklist
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Time Line Followback Interview
  • Time Frame: 12 weeks
    Safety Issue?: No
• CBT Session Adherence
  • Time Frame: 12 weeks
    Safety Issue?: No
• Marijuana craving
  • Time Frame: 12 weeks
    Safety Issue?: No
• HIV risk
  • Time Frame: 12 weeks
    Safety Issue?: No
• Ethics questionnaire
  • Time Frame: 12 weeks
    Safety Issue?: No
• Side Effect Form for Children and Adolescents
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Denver Health and Hospital Authority

Overall Clinical Trial Officials and Contacts

Christian C Thurstone, MD Principal Investigator Denver Health  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00399763

Study ID Number: 05-0563

ClinicalTrials.gov Identifier: NCT00399763

Health Authority: United States: Institutional Review Board