Chronic Neuropathic Pain study: Psilocybin
Official title Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN
ClinicalTrials.gov ID: NCT06731335
What this study is testing
What is Psilocybin (PEX010)?
This is an investigational medicine being studied to see if it can help with chronic neuropathic pain. It is designed to interact with serotonin receptors in the brain, which may influence how pain signals are processed.
Also referred to as Magic mushrooms.
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
- The study will check if psilocybin is safe, tolerable, and might reduce pain in people with long‑term nerve pain. It will also see if a larger trial is possible.
- Who it's for
- Adults who have chronic neuropathic pain and are not currently in another pain study.
- What's involved
- Participants will receive either psilocybin or a dextromethorphan placebo in a double‑blind setup, with visits for dosing, monitoring, and pain assessments.
- Time commitment
- The study lasts about a month, with several clinic visits for dosing and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
- 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 to 65
You may be able to join if
- 18-65 years of age
- Diagnosis of chronic neuropathic pain as determined by a pain specialist
- Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS)
- Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no...
- Sufficient command of English to participate in psychotherapy
You likely can't join if
- History of Dextromethorphan addiction or abuse.
- Enzyme CYP2D6 deficient as shown on the pharmacogenetic test.
- Underlying psychiatric conditions: lifetime or family history of a primary psychotic disorder, bipolar disorder, borderline personality disorder...
- Medications that interact with study drugs
- Medical condition that is unstable or inadequately controlled, including cardiovascular disease, liver disease, or end-stage renal disease
- Previous lifetime use of a serotonergic psychedelic drug
See the full eligibility criteria
- 18-65 years of age
- Diagnosis of chronic neuropathic pain as determined by a pain specialist
- Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS)
- Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no self-reported meaningful improvement in symptoms
- Sufficient command of English to participate in psychotherapy
- For participants of childbearing potential, use of a highly effective or double-barrier methods of contraception.
- History of Dextromethorphan addiction or abuse.
- Enzyme CYP2D6 deficient as shown on the pharmacogenetic test.
- Underlying psychiatric conditions: lifetime or family history of a primary psychotic disorder, bipolar disorder, borderline personality disorder, paranoid personality disorder, current suicidal ideation, and substance...
- Medications that interact with study drugs
- Medical condition that is unstable or inadequately controlled, including cardiovascular disease, liver disease, or end-stage renal disease
- Previous lifetime use of a serotonergic psychedelic drug
- Nursing or pregnant women.
- 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 is enrolling
- 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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.