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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Deep repetitive transcranial magnetic stimulation (dTMS) uses transient electromagnetic fields to stimulate the brain and is approved by Health Canada and the FDA for the treatment of depression, anxious depression, obsessive-compulsive disorder, and tobacco use disorder. Compared to the traditional TMS, dTMS is able to target brain depths ranging from 2 to 6 cm. With the use of various H-coils, dTMS has been used to target specific neural networks with the aim of producing desired clinical effects in psychiatric populations. The intervention in this study is the H4 dTMS coil which stimulates the lateral prefrontal cortex and the insula in the brain.
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
RECRUITINGFeasibility of H4 deep dTMS coils in adults with cannabis use disorder.
To determine the protocol feasibility, the percentage of intervention sessions completed by the participants will be examined
Time frame: End of intervention period (~4 weeks)
Tolerability of H4 deep dTMS coils in adults with cannabis use disorder.
To determine the protocol tolerability, the percentage of withdrawn participants will be examined
Time frame: End of intervention period (~4 weeks)
Safety of H4 deep dTMS coils in adults with cannabis use disorder.
To determine the protocol safety, weekly adverse events reported will be examined
Time frame: End of intervention period (~4 weeks)
Effects of H4 deep rTMS on cannabis use frequency
Cannabis use frequency, as measured by percentage of cannabis use days in the past 7 days.
Time frame: End of intervention period (~4 weeks) and 1-month follow-up
Effects of H4 deep rTMS on Cannabis craving
Cannabis cravings will be measured by the Marijuana Craving Scale (12-item scale, higher scores indicate more cravings).
Time frame: End of intervention period (~4 weeks) and 1-month follow-up
Effects of H4 deep rTMS on motivation to quit Cannabis
Motivation to quit Cannabis use will be measured by the Readiness Ruler (0-10 scale), higher scores indicate more motivation to quit.
Time frame: End of intervention period (~4 weeks) and 1-month follow-up
Effects of H4 deep rTMS on resting state neural activity
Resting state electroencephalography (EEG) will be assessed to examine neural activity changes in the brain.
Time frame: End of intervention period (~4 weeks) and 1-month follow-up
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