Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)
4 other identifiers
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedNovember 7, 2012
November 1, 2012
1.5 years
September 16, 2005
November 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Symptoms of ADHD and SUD (measured at Week 12)
12 Weeks (LOCF)
Study Arms (2)
1
PLACEBO COMPARATORTreatment with placebo or atomoxetine for 12 weeks.
2
EXPERIMENTALInterventions
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 up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy E. Wilens
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
September 1, 2004
Primary Completion
March 1, 2006
Study Completion
April 1, 2006
Last Updated
November 7, 2012
Record last verified: 2012-11