Clinical trial NCT06114212: Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use Disorder
Keywords: Transcranial Magnetic Stimulation
H4 coil
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Feasibility of H4 deep dTMS coils in adults with cannabis use disorder.
timeFrame: End of intervention period (~4 weeks)
measure: Tolerability of H4 deep dTMS coils in adults with cannabis use disorder.
timeFrame: End of intervention period (~4 weeks)
measure: Safety of H4 deep dTMS coils in adults with cannabis use disorder.
timeFrame: End of intervention period (~4 weeks)
Secondary outcomes:
measure: Effects of H4 deep rTMS on cannabis use frequency
timeFrame: End of intervention period (~4 weeks) and 1-month follow-up
measure: Effects of H4 deep rTMS on Cannabis craving
timeFrame: End of intervention period (~4 weeks) and 1-month follow-up
measure: Effects of H4 deep rTMS on motivation to quit Cannabis
timeFrame: End of intervention period (~4 weeks) and 1-month follow-up
measure: Effects of H4 deep rTMS on resting state neural activity
timeFrame: End of intervention period (~4 weeks) and 1-month follow-up
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References: