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New treatment option for Chronic Neuropathic Pain
Official title Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial
ClinicalTrials.gov ID: NCT07301632
What this study is testing
What is 3,4-Methylenedioxymethamphetamine?
3,4-Methylenedioxymethamphetamine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic neuropathic pain.
Also referred to as MDMA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Consenting adults 18 years and older.
- Diagnosis of chronic neuropathic pain (greater than 3 months in duration) by a clinician with specialized training in chronic pain, confirmed with...
- Suffering from moderate-to-severe pain as defined by
- Baseline Patient Reported Outcomes Measurement System - Pain Interference (PROMIS-PI) score of greater than or equal to 60
- An average pain intensity of greater than or equal to 5 on a 0-10 numeric rating scale,43
You likely can't join if
- Past or current history of a psychotic disorder, mania, hypomania, bipolarity, current suicidal ideation, stimulant use disorder (i.e., cocaine...
- Participants with a history of suicide attempts are not excluded unless a significant risk of suicidal behavior is present at the time of screening...
- History of prior MDMA use (excluded to maintain blinding integrity)
- Long QT syndrome, measured by an ECG with a QTc more than 450 ms for males, and 470 ms for females.
- Presence of a relative or absolute contraindication to MDMA or Methylphenidate:
- Pre-existing cardiovascular disorders evidenced in clinical records or disclosed on patient self-report, such as: uncontrolled hypertension...
See the full eligibility criteria
Who can join
- Consenting adults 18 years and older.
- Diagnosis of chronic neuropathic pain (greater than 3 months in duration) by a clinician with specialized training in chronic pain, confirmed with the standardized Leeds Assessment of Neuropathic Symptoms and Signs...
- Suffering from moderate-to-severe pain as defined by
- Baseline Patient Reported Outcomes Measurement System - Pain Interference (PROMIS-PI) score of greater than or equal to 60
- An average pain intensity of greater than or equal to 5 on a 0-10 numeric rating scale,43
- Treatment-refractory pain as defined by a failure of ≥2 medications recommended in the Canadian consensus guidelines on the management of CNP to generate self-reported meaningful improvement in symptoms.
- For participants of childbearing potential, use of a highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the participant.
- Sufficient English skills to participate in psychotherapy.
What rules you out
- Past or current history of a psychotic disorder, mania, hypomania, bipolarity, current suicidal ideation, stimulant use disorder (i.e., cocaine, amphetamine, methamphetamine, MDMA, methylphenidate (Ritalin), etc , and...
- Participants with a history of suicide attempts are not excluded unless a significant risk of suicidal behavior is present at the time of screening as determined by the CRSS (Columbia suicide rating scale)
- History of prior MDMA use (excluded to maintain blinding integrity)
- Long QT syndrome, measured by an ECG with a QTc more than 450 ms for males, and 470 ms for females.
- Presence of a relative or absolute contraindication to MDMA or Methylphenidate:
- Pre-existing cardiovascular disorders evidenced in clinical records or disclosed on patient self-report, such as: uncontrolled hypertension (sustained blood pressure ≥160/100 mmHg), angina (ongoing angina at rest...
- Cerebrovascular conditions: acute stroke or recent history of intracerebral hemorrhage (ischemic or hemorrhagic stroke occurring within the past 6 months)
- Conditions at risk of elevation of blood pressure and increase heart rate, such as glaucoma, tension, agitation, thyrotoxicosis, pheochromocytoma
- Motor tics and/or family history or diagnosis of Tourette's syndrome
- Moderate to severe chronic kidney disease or kidney failure, such as requiring dialysis, significant treatment adjustments for kidney function, or regular nephrologist follow-up)
- Moderate to severe liver disease, such as cirrhosis, a history of significant jaundice unrelated to temporary illness, or any liver condition requiring regular monitoring by a specialist).
- Current treatment with selective serotonin reuptake inhibitors (SSRI's) and serotonin-norepinephrine reuptake inhibitors (SNRI's), tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans) and 5-HT3...
- Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (methylphenidate contains lactose)
- Seizure disorders
- Pregnancy, or breastfeeding
- Known hypersensitivity to study drugs or any study drug excipients
- Medications that interact with study drugs including:
- Any lifetime history use of any stimulant medication (e.g., Adderall, Vyvanse, Ritalin)
- Caffeine intake within 24 hours
- Monoamine oxidase inhibitors (MAOI) within 14 days (e.g. phenelzine, moclobemide, isoniazid, linezolid, phenelzine, harmine) due to risk of hypertensive crisis
- CYP2D6 substrates and modifiers (such as: buproprion, fluoxetine, paroxetine, duloxetine, mirabegron).
- Adrenergic agents (e.g. clonidine) risk of sudden death
- Vasopressor agents (ephedrine pseudoephedrine)
- Coumarin anticoagulants (e.g., warfarin),
- Anticonvulsants (e.g., phenobarbital, diphenylhydantoin, primidone)
- Anti-psychotics and inhibitors of dopamine uptake (e.g. haloperidol, DOPA, tricyclic antidepressants)
- Concomitant medication that could prolong ECG QT interval (e.g. ondansetron, risperidone, methadone)
- Selective Serotonin Reuptake Inhibitors (citalopram, sertraline, fluvoxamine, escitalopram)
- Selective Norepinephrine Uptake Inhibitors (e.g. venlafaxine, duloxetine); Serotonergic Drugs (e.g. dextromethorphan, fentanyl, St. John's Wort, tramadol, 5-hydroxytryptophan); serotonin 5-HT1 receptor agonists...
- Currently engaged in psychotherapy for CNP (other psychotherapy for non-CNP is allowed).
- Any other clinically significant medical illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.