Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

NCT ID: NCT06114212

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Cannabis Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

dTMS stimulation via the H4 coil

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

James MacKillop

Director, Peter Boris Centre for Addiction Research; Director, Michael G. DeGroote Centre for Medicinal Cannabis Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

James MacKillop, PhD, CPsych, FCAHS

Role: CONTACT

jmackill@mcmaster.ca

905-522-1155 ext. 39492

Dante Duarte, MD, PhD

Role: CONTACT

duartedante@mcmaster.ca

905-522-1155 ext. 36782

Facility Contacts

James MacKillop, PhD, CPsych, FCAHS

Role: primary

jmackill@mcmaster.ca

905-522-1155 ext. 39492

Dante Duarte, MD, PhD

Role: backup

duartedante@mcmaster.ca

905-522-1155 ext. 36782

Other Identifiers

16698

Identifier Type: -

Identifier Source: org_study_id