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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Contact Information
Primary
James MacKillop, PhD, CPsych, FCAHS
jmackill@mcmaster.ca
905-522-1155
Backup
Dante Duarte, MD, PhD
duartedante@mcmaster.ca
905-522-1155
Time Frame
Start Date: 2024-03-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 10
Treatments
Experimental: 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).
Related Therapeutic Areas
Sponsors
Leads: St. Joseph's Healthcare Hamilton

This content was sourced from clinicaltrials.gov