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

St. Joseph's Healthcare Hamilton

Status: Enrolling

Conditions: Cannabis Use Disorder

Treatments: Device: dTMS stimulation via the H4 coil

Study type: Interventional

Funder types: Other

Identifiers

NCT06114212

16698

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

H4 dTMS

Experimental group

Description:

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).

Treatment:

Device: dTMS stimulation via the H4 coil