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OpenTrials
Completed

NCT Number: NCT06114212

Deep Repetitive Transcranial Magnetic Stimulation for 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.

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Key information

Conditions

Cannabis Use Disorder

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study 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

Acronym: TRANS-CANN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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