Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07301632

Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial

Led by Unity Health Toronto · Updated on 2026-02-13

40

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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, triple blinded study. 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).

CONDITIONS

Official Title

Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consenting adults 18 years and older
  • Diagnosis of chronic neuropathic pain lasting more than 3 months confirmed by a specialist
  • Moderate-to-severe pain with PROMIS-PI score of 60 or higher
  • Average pain intensity of 5 or higher on a 0-10 scale
  • Pain not adequately improved by at least 2 recommended medications
  • Use of highly effective or double-barrier contraception if of childbearing potential, or abstinence
  • Sufficient English language skills to participate in psychotherapy
Not Eligible

You will not qualify if you...

  • History or current diagnosis of psychotic disorder, mania, hypomania, bipolar disorder, or current suicidal ideation
  • Stimulant use disorder or other substance use disorder in past 12 months
  • Prior MDMA use
  • Long QT syndrome (QTc >450 ms for males, >470 ms for females)
  • Cardiovascular disorders including uncontrolled hypertension, angina, recent acute coronary syndrome, revascularization within 6 months, arterial occlusive disease, heart failure, congenital heart disease, cardiomyopathies, recent myocardial infarction, serious arrhythmias, channelopathies, aneurysmal vascular disease, or advanced arteriosclerosis
  • Recent stroke or intracerebral hemorrhage within 6 months
  • Conditions that risk elevated blood pressure or heart rate such as glaucoma, agitation, thyrotoxicosis, pheochromocytoma
  • Motor tics or Tourette's syndrome diagnosis or family history
  • Moderate to severe chronic kidney disease or kidney failure requiring dialysis or specialist follow-up
  • Moderate to severe liver disease requiring specialist monitoring
  • Current treatment with SSRIs, SNRIs, tricyclic antidepressants, serotonin receptor agonists or antagonists
  • Hereditary galactose intolerance or related conditions
  • Seizure disorders
  • Pregnancy or breastfeeding
  • Known allergy to study drugs or excipients
  • Use of stimulant medications ever
  • Caffeine intake within 24 hours of study
  • Use of monoamine oxidase inhibitors within 14 days
  • Use of medications that interact with study drugs including CYP2D6 substrates, adrenergic agents, vasopressors, anticoagulants, anticonvulsants, antipsychotics, dopamine uptake inhibitors, medications prolonging QT interval, serotonergic drugs
  • Currently engaged in psychotherapy for chronic neuropathic pain
  • Any other significant medical illness that could affect study results or participant safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

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Research Team

A

Akash Goel, MD,MPH,FRCPC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial | DecenTrialz