Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial

This is a Health Canada regulated internal pilot study designed to assess the feasibility, tolerability, and preliminary efficacy of 3, 4-methylenedioxymethamphetamine hydrochloride capsules-AT for chronic neuropathic pain to inform a larger, fully powered multi-center study. This is an interventional, randomized, 2-arm parallel, blinded (Treating and dosing physician, Patient Outcome assessor and psychotherapist). The total study duration is 2 years. Participants will receive preparatory psychotherapy session during week 2 and week 4 followed by a combined single dosing session with psychotherapy during week 6. Integrative psychotherapy will follow at weeks 6, 8, 12, and 16. Follow up for primary clinical endpoint at week 16; final follow up for secondary clinical endpoint at 16-weeks. Participants will be asked to complete adjunctive home psychotherapy in the form of online modules. Data collected will be entered in electronic case report form (REDCap Academic).

NCT Number	NCT07301632
Lead Sponsor	Unity Health Toronto
Conditions	Chronic Neuropathic Pain
Enrollment	50 participants
Start Date	2026-01-30
Primary Completion	2027-12-01 (estimated)
Study Completion	2028-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-29