Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06114212
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2023-10-06
Brief Title:
Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Phase 1 Open-Label Pilot Trial of Deep Repetitive Transcranial Stimulation of the Lateral Prefrontal Cortex and Insula for Adults With Moderate-to-Severe Cannabis Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
There is a credible basis for lateral prefrontal cortex and insula deep repetitive transcranial magnetic stimulation dTMS stimulation as a treatment for cannabis use disorder CUD but no studies to date have examined this Evidence of benefit could expand the treatment options available for CUD but require randomized controlled trials RCTs to evaluate its efficacy Toward an RCT of this intervention the proposed study is a phase 1 open-label pilot trial of dTMS for adults with CUD This study will establish the viability of an H4 protocol constituting an active arm of a future double-blind RCT
Detailed Description:
Deep repetitive transcranial magnetic stimulation dTMS is a technique that stimulates areas of the brain using magnetic pulses and is an approved treatment for several mental health and substance use disorders The treatment uses head coils to deliver the magnetic pulses A dTMS coil called the H4 coil stimulates the lateral prefrontal cortex and insula and has been approved for the treatment of tobacco use disorder No studies have been conducted on the H4 coil for treat cannabis use disorder The purpose of this pilot study is to determine feasibility and tolerability of a dTMS H4 protocol The goal is to lay the foundation for randomized controlled trials of dTMS as a treatment for adults with moderate-to-severe cannabis use disorder
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