Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00218322

Enrollment

108

Registered

2005-09-22

Start date

2004-09-30

Completion date

2006-04-30

Last updated

2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity, Substance-Related Disorders

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.

Interventions

DRUGAtomoxetine 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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame
Symptoms of ADHD and SUD (measured at Week 12)	12 Weeks (LOCF)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026