Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

NCT06114212 | Completed

• 1 other identifier: 16698
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Keywords

Transcranial Magnetic Stimulation; H4 coil

Outcome Measures

Primary Outcomes (3)

• Feasibility 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

  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  To determine the protocol tolerability, the percentage of withdrawn participants will be examined

  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

  End of intervention period (~4 weeks)

Secondary Outcomes (4)

• Effects of H4 deep rTMS on cannabis use frequency

  End of intervention period (~4 weeks) and 1-month follow-up

• Effects of H4 deep rTMS on Cannabis craving

  End of intervention period (~4 weeks) and 1-month follow-up

• Effects of H4 deep rTMS on motivation to quit Cannabis

  End of intervention period (~4 weeks) and 1-month follow-up

• Effects of H4 deep rTMS on resting state neural activity

  End of intervention period (~4 weeks) and 1-month follow-up

Study Arms (1)

H4 dTMS

EXPERIMENTAL

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).

Device: dTMS stimulation via the H4 coil

Interventions

dTMS stimulation via the H4 coil DEVICE

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.

H4 dTMS

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, age 25-65
• DSM-5 CUD, moderate or higher (4+ DSM-5 symptoms)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

Location

Related Publications (1)

• MacKillop J, McIntyre-Wood C, Vandehei E, Yaya H, Di Passa AM, Prokop-Millar S, Fein A, Yang A, Elsayed M, Schwartzmann B, Farzan F, MacKillop E, Duarte D. Phase 1 Open-Label Pilot Trial of H4 Deep Repetitive Transcranial Magnetic Stimulation for Adults With Moderate-to-Severe Cannabis Use Disorder. Neuromodulation. 2026 Feb 23:S1094-7159(26)00008-5. doi: 10.1016/j.neurom.2026.01.003. Online ahead of print.

  PMID: 41733532 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Peter Boris Centre for Addiction Research; Director, Michael G. DeGroote Centre for Medicinal Cannabis Research

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: November 2, 2023
• Study Start: March 26, 2024
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data and supporting documents will be made available following the publication of the primary findings.
• Access Criteria: Doctoral-level researcher with an appointment at professional research organization.

Locations

CA (1)