Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399763
• Other study ID #: 05-0563
• Status: Completed
• Phase: N/A
• First received: November 13, 2006
• Last updated: June 12, 2015
• Start date: September 2005
• Est. completion date: February 2008

Study information

• Verified date: June 2015
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis
• Substance Abuse
• Substance-Related Disorders

Intervention

Drug:
• Atomoxetine
Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
• Placebo
Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	American Academy of Child Adolescent Psychiatry.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist	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.	baseline and weekly through week 12 post randomization	No
Secondary	Time Line Followback Interview (TLFB)	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.	12 weeks	No
Secondary	Side Effect Form for Children and Adolescents (SEFCA)	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.	weekly from randomization to 12 weeks post-randomization	Yes