Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

Substance-Related Disorders Clinical Trial

Official title:

Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218322
• Other study ID #: NIDA-16264-1
• Secondary ID: K24DA016264K24-1
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: November 6, 2012
• Start date: September 2004
• Est. completion date: April 2006

Study information

• Verified date: November 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

Description:

High rates of ADHD have been reported in adolescents with SUD. In addition, untreated ADHD is a risk factor for developing SUD. Atomoxetine is a norepinephrine reuptake inhibitor, and is currently used to treat adolescents with ADHD. The purpose of this trial is to evaluate the efficacy of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

This study will last up to 18 weeks. Participants will receive six treatments of manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks. Participants and their parents will partake in therapy sessions. Subjects who have completed at least 2 weeks of CBT will be eligible to enter the controlled trial, at which point participants will be randomly assigned to receive either atomoxetine or placebo, which they will take once daily for 12 weeks. At the Week 12 study visit, participants will be assessed for symptoms of ADHD and SUD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

• DSM-IV diagnosis of ADHD

• Current or recent (within the three months prior to study entry) SUD, including marijuana and alcohol abuse

• ADHD CGI-S score of greater to or equal to 4

Exclusion Criteria:

• Any Unstable medical condition

• Recent history of intravenous drug use or cocaine dependence

• Currently abusing ecstasy, cocaine, gamma-hydroxybutyrate, methamphetamine, amphetamine, opioids, phencyclidine, or benzodiazepine

• Mental retardation or organic brain syndrome

• Currently psychotic or history of bipolar disorder

• Currently taking any psychotropic or anti-substance abuse disorder medications

• Current DSM-IV diagnosis of major depression, depressive disorder, or anorexia

• Pregnant or breastfeeding

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Atomoxetine hydrochloride
Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
• Placebo
Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of ADHD and SUD (measured at Week 12)		12 Weeks (LOCF)	No