Ecstasy for Neuropathic Pain
(EASEPain Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if ecstasy (MDMA) can alleviate chronic neuropathic pain, which results from nerve damage. Researchers seek to evaluate the treatment's effectiveness and safety for individuals who have not found relief from other medications. Participants will receive either the treatment or a placebo and will have psychological support throughout the study. This trial is suitable for those who have experienced moderate to severe neuropathic pain for over three months and have not found success with at least two other pain medications. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants currently taking specific medications like SSRIs, SNRIs, tricyclic antidepressants, and others due to potential interactions. It's important to discuss your current medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ecstasy, also known as MDMA, has been studied for its safety in humans. One study found no serious side effects linked to the drug, and participants did not experience major changes in blood pressure or mental function. However, those using MDMA in therapy sessions reported mild side effects more often than those taking a placebo.
MDMA has also shown promise in reducing long-term pain in people with PTSD, suggesting it might help with nerve-related pain as well. Although some studies in mice have indicated possible cell damage with heavy use, these findings do not apply to the controlled doses used in clinical trials. Overall, current research suggests MDMA is generally well-tolerated in a clinical setting.12345Why do researchers think this study treatment might be promising for neuropathic pain?
Most treatments for neuropathic pain rely on medications like gabapentin or pregabalin, which target nerve signals. But researchers are excited about using Ecstasy, known scientifically as 3,4-Methylenedioxymethamphetamine (MDMA), because it works differently. MDMA may alleviate pain by affecting serotonin pathways in the brain, potentially offering relief through a new mechanism not tapped by current medications. This approach could provide a faster-acting and more robust solution for patients who don't respond well to traditional treatments. Additionally, the combination of MDMA with psychological support might enhance its effectiveness, addressing both the physical and emotional aspects of chronic pain.
What evidence suggests that Ecstasy might be an effective treatment for neuropathic pain?
Research has shown that MDMA (the main ingredient in ecstasy) used with therapy yields promising results in reducing long-term pain, especially for people with PTSD (post-traumatic stress disorder). In earlier studies, therapy with MDMA led to a clear drop in pain levels. The treatment provides rapid relief, which is an important finding. In this trial, participants will receive either MDMA or a placebo (Methylphenidate) to assess its effects on long-lasting nerve pain. Early results suggest that MDMA might offer a new way to manage pain.36789
Who Is on the Research Team?
Akash Goel, MD,MPH,FRCPC
Principal Investigator
Unity Health Toronto
Are You a Good Fit for This Trial?
Adults over 18 with chronic neuropathic pain lasting more than 3 months, who rate their pain intensity at 5 or higher and have not found relief from at least two other medications. Participants must be able to communicate in English and agree to use effective contraception if of childbearing potential.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparatory Psychotherapy
Participants undergo preparatory psychotherapy sessions and complete workbooks
Treatment
Participants receive a single dosing session with psychotherapy and optional supplemental dose
Integrative Psychotherapy
Participants engage in integrative psychotherapy sessions and complete workbooks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ecstasy
Trial Overview
The trial is testing the effects of MDMA capsules combined with psychotherapy versus Methylphenidate for treating severe chronic neuropathic pain. It's a randomized, double-blind study including preparatory and integrative psychotherapy sessions over a period of 16 weeks.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Treatment Arm: 3,4-Methylenedioxymethamphetamine 120mg (3 x 40mg capsule) PO single dose plus psychological support; optional 40mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose 160mg)
Placebo arm: Methylphenidate 30mg (3 x 10mg capsule) PO single dose plus psychological support; optional 10mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose of 40 mg)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor
Citations
Prospective Preference for Ecstasy Trial for Chronic Pain
Conclusions: The results of this study indicate a strong willingness among patients with chronic pain to participate in the EASE-Pain trial.
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, ...
MDMA-Assisted Therapy Reduces Chronic Pain in PTSD
MDMA-assisted therapy is associated with a reduction in chronic pain among people with post-traumatic stress disorder. Introduction: Increasing ...
Trial will test if MDMA brings relief for chronic nerve pain
A first-of-its-kind global trial to test the impact of MDMA, commonly known as ecstasy, on chronic nerve pain compared with a placebo.
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webapps.cihr-irsc.gc.ca
webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=521737&lang=enDetailed information - Funding Decisions Database - CIHR
MDMA (the active component in 'ecstasy'), when combined with CBT/MM (i.e. MDMA Assisted Psychotherapy [MDMA-AT]) has demonstrated rapid onset of pain relief ( ...
the first randomized controlled pilot study
There were no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases. MDMA-assisted ...
Side-effects of mdma-assisted psychotherapy: a systematic ...
In Phase 2 studies, MDMA-AP participants had 1.7 times greater odds of experiencing any side effect during medication sessions than placebo ...
A review on the mitochondrial toxicity of “ecstasy” (3,4- ...
In this review, we describe the most relevant MDMA effects at the mitochondrial level found in in vitro and in vivo models, these later conducted in mice and ...
3,4-methylenedioxymethamphetamine (MDMA): current ...
Possible neurotoxicity in heavy ecstasy users has been revealed by neuroimaging studies showing reduced SERT binding and increased 5-HT2A receptor binding in ...
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