Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

Not Applicable

Recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

Adult, age 25-65
DSM-5 CUD, moderate or higher (4+ DSM-5 symptoms)
4 or more days of cannabis use per week
Reports inhalation as one route of administration
Treatment-seeking (i.e., self-reported readiness to change of 5 or greater on a 0-10 readiness ruler)
Stable domicile and reliable transportation, and willingness to attend in-person visits at SJHH Hamilton.

Exclusion Criteria

Current psychotic symptoms, history of schizophrenia-spectrum disorders or bipolar disorder, or current PTSD
Active suicidality (past 3 months) or history of severe suicidality (i.e., requiring hospitalization)
Any other mental health condition deemed incompatible by the team
High risk alcohol involvement and/or 4+ symptoms of alcohol use disorder
Unstable management of an existing mental health condition or anticipation of a change to the treatment over the next 3 months
Current unstable medical condition (e.g., diabetes)
rTMS Contraindications: intracranial or metal implants in the head or nearby regions that cannot be safely removed; history of epilepsy or seizures; pregnancy (female participants only); pacemaker and/or implantable cardioverter-defibrillators).
Medication contraindications (e.g., bupropion >300 mg/day due to risk of seizures, benzodiazepine equivalent dose to lorazepam >2 mg/day).
History of recurrent headache or migraine (past year)
Significant literacy, visual, or hearing problems
Co-enrollment in a clinical drug trial

Arm && Interventions

Group	Intervention	Description
H4 dTMS	dTMS stimulation via the H4 coil	The participants will receive 18 H4 dTMS sessions over 4-6 weeks as an adjunct to evidence-based standard care for CUD (i.e., motivational interviewing and contingency management).

Primary Outcome Measures

Name	Time	Method
Feasibility of H4 deep dTMS coils in adults with cannabis use disorder.	End of intervention period (~4 weeks)	To determine the protocol feasibility, the percentage of intervention sessions completed by the participants will be examined
Tolerability of H4 deep dTMS coils in adults with cannabis use disorder.	End of intervention period (~4 weeks)	To determine the protocol tolerability, the percentage of withdrawn participants will be examined
Safety of H4 deep dTMS coils in adults with cannabis use disorder.	End of intervention period (~4 weeks)	To determine the protocol safety, weekly adverse events reported will be examined

Secondary Outcome Measures

Name	Time	Method
Effects of H4 deep rTMS on cannabis use frequency	End of intervention period (~4 weeks) and 1-month follow-up	Cannabis use frequency, as measured by percentage of cannabis use days in the past 7 days.
Effects of H4 deep rTMS on motivation to quit Cannabis	End of intervention period (~4 weeks) and 1-month follow-up	Motivation to quit Cannabis use will be measured by the Readiness Ruler (0-10 scale), higher scores indicate more motivation to quit.
Effects of H4 deep rTMS on resting state neural activity	End of intervention period (~4 weeks) and 1-month follow-up	Resting state electroencephalography (EEG) will be assessed to examine neural activity changes in the brain.
Effects of H4 deep rTMS on Cannabis craving	End of intervention period (~4 weeks) and 1-month follow-up	Cannabis cravings will be measured by the Marijuana Craving Scale (12-item scale, higher scores indicate more cravings).

Locations (1): St. Joseph's Healthcare Hamilton
🇨🇦
Hamilton, Ontario, Canada