Viewing Study NCT04785456



Ignite Creation Date: 2024-05-06 @ 3:52 PM
Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04785456
Status: COMPLETED
Last Update Posted: 2024-03-05
First Post: 2021-02-12

Brief Title: rTMS for Suicidality in Opioid Use Disorder
Sponsor: Centre for Addiction and Mental Health
Organization: Centre for Addiction and Mental Health

Study Overview

Official Title: Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders
Status: COMPLETED
Status Verified Date: 2024-03
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: This trial is a randomized double blind controlled pilot study that will compare bilateral theta burst stimulation TBS and sham treatment for patients with opioid use disorder OUD and Major Depressive Disorder MDD experiencing suicidality
Detailed Description: Repetitive transcranial magnetic stimulation rTMS to the dorsolateral prefrontal cortex DLPFC is used therapeutically in major depressive disorder resistant to standard treatments and recently also shown to be effective in reducing suicidality with a bilateral approach Recently a new form of rTMS has been developed called theta burst stimulation TBS which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS The investigators propose to conduct a randomized controlled clinical trial of a daily 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD craving for opioids and rates of relapse to opioid use The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography TMS-EEG will be assessed before and after intervention Clinical outcomes measured before during at end of treatment and 4-weeks post treatment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None