Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Disorder With Hyperactivity; Substance-Related Disorders

Treatments: Drug: Placebo; Drug: Atomoxetine hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00218322

K24DA016264 (U.S. NIH Grant/Contract)

NIDA-16264-1

DPMC

K24-16264-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 15 to 30 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Treatment with placebo or atomoxetine for 12 weeks.

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: Atomoxetine hydrochloride