Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218322
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2005-09-16
Brief Title:
Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder ADHD and Substance Use Disorder SUD
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchK24DA016264 |
| K24DA016264 | NIH | None | None |
| K24-16264-1 | None | None | None |