Actively Recruiting
Ecstasy to Alleviate SEvere Chronic Neuropathic Pain (EASE Pain) Trial: A Randomized Controlled Pilot Trial
Led by Unity Health Toronto · Updated on 2026-02-13
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility, tolerability, and preliminary effects of 3,4-methylenedioxymethamphetamine hydrochloride capsules for treating chronic neuropathic pain. This phase II, randomized, triple-blinded pilot study aims to inform a larger multi-center trial by assessing recruitment, data completion, blinding, and safety outcomes over 16 weeks in adults with moderate-to-severe chronic neuropathic pain. Participants are randomly assigned to receive either a single oral dose of 120 mg 3,4-methylenedioxymethamphetamine (with an optional 40 mg supplement) plus psychological support, or a placebo of methylphenidate 30 mg (with optional 10 mg supplement) plus psychological support. Psychological therapy includes preparatory sessions during weeks 1 to 5, a combined dosing and psychotherapy session at week 6, and integrative psychotherapy sessions through week 16. Adjunctive home psychotherapy modules are completed online. Throughout the study, participants undergo multiple assessments including questionnaires on pain, function, mood, anxiety, PTSD symptoms, health status, side effects, and drug effects at scheduled weeks. Adverse events and participant retention are closely monitored, with primary and secondary outcomes evaluated at week 16. Data are collected electronically, and overall study duration is two years with each participant involved for 16 weeks.
CONDITIONS
Brief Title
Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with chronic neuropathic pain lasting more than 3 months confirmed by a specialist
- Moderate-to-severe pain with PROMIS Pain Interference score of 60 or higher
- Average pain intensity of 5 or greater on a 0-10 scale
- Treatment-resistant pain with failure of two or more recommended medications
- Use of effective contraception if of childbearing potential
- Sufficient English skills to participate in psychotherapy
You will not qualify if you...
- History or current diagnosis of psychotic disorder, mania, bipolar disorder, or stimulant use disorder within past 12 months
- Current suicidal ideation or significant suicide risk
- Prior use of MDMA
- Long QT syndrome or abnormal ECG
- Certain cardiovascular or cerebrovascular conditions
- Conditions that increase blood pressure or heart rate risk
- Motor tics or Tourette's syndrome
- Moderate to severe kidney or liver disease
- Current treatment with SSRIs, SNRIs, tricyclic antidepressants, and some other medications
- Hereditary lactose intolerance or related disorders
- Seizure disorders
- Pregnancy or breastfeeding
- Known allergy to study drugs or ingredients
- Use of stimulant medications or caffeine within 24 hours prior
- Use of monoamine oxidase inhibitors within 14 days
- Use of several interacting medications that may affect safety
- Currently undergoing psychotherapy for chronic neuropathic pain
- Any other significant medical illness affecting study safety or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Weeks 1 to 5
Participants engage in preparatory psychotherapy sessions and workbook activities to prepare for the treatment phase.
Weekly visits for psychotherapy sessions and workbook activities
Duration - Week 6 to Week 16
Participants receive a single dose of the study drug or placebo along with psychological support, followed by integrative psychotherapy sessions.
1 dosing session with in-person psychotherapy at Week 6, followed by weekly psychotherapy integration sessions and workbook activities
Duration - Up to Week 16
Participants complete questionnaires and adverse event follow-ups to assess treatment effects and safety up to Week 16.
Questionnaires and adverse event follow-up visits at Weeks 7, 10, 11, and 16
Trial Site Locations
Total: 1 location
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
Research Team
A
Akash Goel, MD,MPH,FRCPC
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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