Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

November 6, 2012 updated by: Timothy Wilens, MD, Massachusetts General Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
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 Comparator: 1
Treatment with placebo or atomoxetine for 12 weeks.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms of ADHD and SUD (measured at Week 12)
Time Frame: 12 Weeks (LOCF)
12 Weeks (LOCF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Timothy E. Wilens, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 6, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-16264-1
  • DPMC (Other Identifier: NIDA)
  • K24DA016264 (U.S. NIH Grant/Contract)
  • K24-16264-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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