Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder (TRANS-CANN)

March 25, 2026 updated by: James MacKillop, St. Joseph's Healthcare Hamilton

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3K7
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H4 dTMS
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of H4 deep dTMS coils in adults with cannabis use disorder.
Time Frame: End of intervention period (~4 weeks)
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.
Time Frame: End of intervention period (~4 weeks)
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.
Time Frame: End of intervention period (~4 weeks)
To determine the protocol safety, weekly adverse events reported will be examined
End of intervention period (~4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of H4 deep rTMS on cannabis use frequency
Time Frame: 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.
End of intervention period (~4 weeks) and 1-month follow-up
Effects of H4 deep rTMS on Cannabis craving
Time Frame: 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).
End of intervention period (~4 weeks) and 1-month follow-up
Effects of H4 deep rTMS on motivation to quit Cannabis
Time Frame: 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.
End of intervention period (~4 weeks) and 1-month follow-up
Effects of H4 deep rTMS on resting state neural activity
Time Frame: 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.
End of intervention period (~4 weeks) and 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Actual)

April 17, 2025

Study Completion (Actual)

April 17, 2025

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

The data and supporting documents will be made available following the publication of the primary findings.

IPD Sharing Access Criteria

Doctoral-level researcher with an appointment at professional research organization.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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