Using deep brain stimulation to treat cannabis use disorder
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
This study is testing if a new brain stimulation treatment can help adults with cannabis use disorder reduce their cravings and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06114212 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the use of deep repetitive transcranial magnetic stimulation (dTMS) with an H4 coil to treat adults with cannabis use disorder (CUD). The study aims to assess the feasibility and tolerability of this treatment approach, which has previously been approved for other substance use disorders. By stimulating specific brain regions, the trial seeks to establish a foundation for future randomized controlled trials evaluating the efficacy of dTMS for CUD. Participants will receive dTMS treatment while being monitored for their response and any side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-65 with moderate to severe cannabis use disorder who are actively seeking treatment.
Not a fit: Patients with current psychotic symptoms, severe mental health conditions, or unstable medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals struggling with cannabis use disorder.
How similar studies have performed: While dTMS has been effective for other substance use disorders, this specific application for cannabis use disorder is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: James MacKillop, PhD, CPsych, FCAHS
- Email: jmackill@mcmaster.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.