AzTrials
AzTrials

Cannabis Use DisorderTRANS-CANNNCT06114212

Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

A study testing dTMS stimulation via the H4 coil in people with Cannabis Use Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Cannabis Use Disorder
What is being tested?
dTMS stimulation via the H4 coil
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
26 Mar 2024to 17 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 3K7

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
dTMS stimulation via the H4 coil
Keywords
Transcranial Magnetic Stimulation, H4 coil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dTMS stimulation via the H4 coilDevice

    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.

Study groups in NCT06114212
Study groupRoleWhat they receive
H4 dTMSExperimentalThe 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).
Receives: Device: dTMS stimulation via the H4 coil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: End of intervention period (~4 weeks)

  2. 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

    Measured: End of intervention period (~4 weeks)

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

    To determine the protocol safety, weekly adverse events reported will be examined

    Measured: End of intervention period (~4 weeks)

Secondary outcomes (4)

  1. 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.

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

  2. 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).

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start26 Mar 2024
  3. Primary completion17 Apr 2025
  4. Study completion17 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06114212
Sponsor's protocol ID
16698
Acronym
TRANS-CANN
Status last verified
Mar 2026
First submitted
6 Oct 2023
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 41733532

Questions about this trial

What is this clinical trial studying?

A study testing dTMS stimulation via the H4 coil in people with Cannabis Use Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of H4 deep dTMS coils in adults with cannabis use disorder. (time frame: End of intervention period (~4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06114212, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in