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Completed

NCT Number: NCT00218322

Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Chemically-Induced Disorders Mental Disorders Neurodevelopmental Disorders Substance-Related Disorders

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atomoxetine Hydrochloride

Drug

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

Drug

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

Primary outcomes

  1. Symptoms of ADHD and SUD (measured at Week 12)

    Time frame: 12 Weeks (LOCF)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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