Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-28 @ 7:32 PM
Study NCT ID:
NCT00142961
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2005-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder
Sponsor:
New York State Psychiatric Institute
Organization:
Study Overview
Official Title:
Marijuana-Abusing Attention Deficit Hyperactivity Disorder (ADHD) Teens: Atomoxetine Treatment
Status:
COMPLETED
Status Verified Date:
2019-04
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:
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
Detailed Description:
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. Therefore, it is important to develop treatments targeting adolescents diagnosed with both ADHD and marijuana dependence. Atomoxetine is currently used to treat individuals diagnosed with ADHD. The purpose of this study is to determine the feasibility of administering atomoxetine in a therapeutic setting to adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms. Finally, this study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo. Study visits will occur 2 times each week for the duration of the 12-week trial. At each study visit, vital signs and medication side effects will be assessed. In addition, psychiatric ratings measurements will be evaluated. Participants will also complete self reports in order to track ADHD-related symptoms. Starting at the Week 2 study visit, all participants will receive psychotherapy sessions. This will involve cognitive-behavioral therapy/relapse prevention treatment that has been designed specifically for ADHD adolescents. The aim of the cognitive skills training will be to assist the participants in developing the skills necessary to manage their drug use as well as the symptoms they experience related to ADHD. At Month 6, a follow-up visit will occur, at which time participants urine toxicology tests will be completed to determine if participants have been using marijuana or any other substances of abuse. In addition, at the Month 6 follow-up visit, participants will complete psychiatric ratings, self reports, and will meet with a physician to assess ADHD-related symptoms.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo. Study visits will occur 2 times each week for the duration of the 12-week trial. At each study visit, vital signs and medication side effects will be assessed. In addition, psychiatric ratings measurements will be evaluated. Participants will also complete self reports in order to track ADHD-related symptoms. Starting at the Week 2 study visit, all participants will receive psychotherapy sessions. This will involve cognitive-behavioral therapy/relapse prevention treatment that has been designed specifically for ADHD adolescents. The aim of the cognitive skills training will be to assist the participants in developing the skills necessary to manage their drug use as well as the symptoms they experience related to ADHD. At Month 6, a follow-up visit will occur, at which time participants urine toxicology tests will be completed to determine if participants have been using marijuana or any other substances of abuse. In addition, at the Month 6 follow-up visit, participants will complete psychiatric ratings, self reports, and will meet with a physician to assess ADHD-related symptoms.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA019233 | NIH | None | https://reporter.nih.gov/quic… | View |
| DPMCDA | None | None | View |