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Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Substance-Related Disorders

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Atomoxetine hydrochloride

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Treatment with placebo or atomoxetine for 12 weeks.

Outcomes

Primary Outcome Measures

Symptoms of ADHD and SUD (measured at Week 12)

Secondary Outcome Measures

Full Information

NCT ID

NCT00218322

First Posted

September 16, 2005

Last Updated

November 6, 2012

Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00218322

Brief Title

Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

March 2006 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder With Hyperactivity, Substance-Related Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Treatment with placebo or atomoxetine for 12 weeks.

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Atomoxetine hydrochloride

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Symptoms of ADHD and SUD (measured at Week 12)

Time Frame

12 Weeks (LOCF)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy E. Wilens

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

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