CompletedNot Applicable

Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

Canada12 participantsStarted 2024-03-26

Plain-language 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.

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of H4 deep dTMS coils in adults with cannabis use disorder.

Timeframe: End of intervention period (~4 weeks)

Tolerability of H4 deep dTMS coils in adults with cannabis use disorder.

Timeframe: End of intervention period (~4 weeks)

Safety of H4 deep dTMS coils in adults with cannabis use disorder.

Timeframe: End of intervention period (~4 weeks)

Trial details

NCT IDNCT06114212

SponsorSt. Joseph's Healthcare Hamilton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-17

View on ClinicalTrials.gov More Cannabis Use Disorder trials

Plain-language summary

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility of H4 deep dTMS coils in adults with cannabis use disorder.

Timeframe: End of intervention period (~4 weeks)

Tolerability of H4 deep dTMS coils in adults with cannabis use disorder.

Timeframe: End of intervention period (~4 weeks)

Safety of H4 deep dTMS coils in adults with cannabis use disorder.

Timeframe: End of intervention period (~4 weeks)