Psilocybin occasioned mystical-type experiences: immediate and persisting dose-related effects.
Roland R Griffiths, Matthew W Johnson, William A Richards...
https://pubmed.ncbi.nlm.nih.gov/21674151Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID06731335
Psilocybin for Enhanced Analgesia in Chronic Neuropathic Pain in Adults
Led by Unity Health Toronto · Updated on 2025-03-30
30
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating psilocybin (magic mushrooms) as a possible treatment to reduce pain in adults with moderate-to-severe chronic neuropathic pain. This phase II study aims to address the lack of clinical evidence by conducting a randomized, double-blinded trial comparing psilocybin to an active placebo. The trial focuses on assessing feasibility, tolerability, and early signs of pain relief to inform a larger future study. Participants will be randomly assigned to receive either a single oral dose of 25 mg psilocybin or a single oral dose of 400 mg dextromethorphan as an active placebo. Both groups will receive psychological support during the study. Follow-up visits are scheduled at 1, 7, 14, 30, and 90 days after dosing to monitor progress and collect data. During the study, participants will undergo assessments of pain intensity and interference, along with monitoring of recruitment success, consent rates, adherence, and any adverse effects. The study team will use questionnaires and patient-reported outcomes to evaluate changes from baseline. The total participation includes these follow-ups over approximately three months, with the main outcome being the feasibility of conducting a larger multicenter trial.
CONDITIONS
Brief Title
Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Be between 18 and 65 years old
- Have a diagnosis of chronic neuropathic pain confirmed by a pain specialist
- Have moderate-to-severe neuropathic pain measured by PROMIS
- Have tried at least two recommended neuropathic pain medications without meaningful symptom improvement
- Have sufficient English skills to participate in psychotherapy
- Use highly effective or double-barrier contraception if of childbearing potential
You will not qualify if you...
- History of addiction or abuse of dextromethorphan
- Deficiency of enzyme CYP2D6 shown by pharmacogenetic test
- Underlying psychiatric conditions including psychotic disorder, bipolar disorder, borderline or paranoid personality disorder, current suicidal thoughts, or recent substance use disorder
- Use of medications that interact with study drugs
- Unstable or uncontrolled medical conditions such as cardiovascular, liver, or end-stage kidney disease
- Previous lifetime use of serotonergic psychedelic drugs
- Pregnancy or nursing
- Any other significant medical illness that may affect study results or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single day
Participants receive a single dose of psilocybin or active placebo along with psychological support.
1 treatment visit (in-person)
Follow-up
Duration - 90 days
Participants are monitored for safety and changes in pain intensity and interference after treatment.
5 follow-up visits on Days 1, 7, 14, 30, and 90
Trial Site Locations
Total: 2 locations
1
St. Michael's Hospital. Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
2
St. Michael's Hospital. Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
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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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Published Research Related To This Trial
Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences.
Theresa M Carbonaro, Matthew P Bradstreet, Frederick S Barrett...
https://pubmed.ncbi.nlm.nih.gov/27578767Preparing for the Bursting of the Psychedelic Hype Bubble.
David B Yaden, James B Potash, Roland R Griffiths
https://pubmed.ncbi.nlm.nih.gov/36044208Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia.
Nicolas G Glynos, Jennifer Pierce, Alan K Davis...
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Vilayanur Ramachandran, Chaipat Chunharas, Zeve Marcus...
https://pubmed.ncbi.nlm.nih.gov/29764303Self-Medication for Chronic Pain Using Classic Psychedelics: A Qualitative Investigation to Inform Future Research.
Julia Bornemann, James B Close, Meg J Spriggs...
https://pubmed.ncbi.nlm.nih.gov/34867525Comorbidity between pain and mental illness - Evidence of a bidirectional relationship.
E Bondesson, F Larrosa Pardo, K Stigmar...
https://pubmed.ncbi.nlm.nih.gov/29577509Structural plasticity and reorganisation in chronic pain.
Rohini Kuner, Herta Flor
https://pubmed.ncbi.nlm.nih.gov/28704354The entropic brain: a theory of conscious states informed by neuroimaging research with psychedelic drugs.
Robin L Carhart-Harris, Robert Leech, Peter J Hellyer...
https://pubmed.ncbi.nlm.nih.gov/24550805Chronic pain and psychedelics: a review and proposed mechanism of action.
Joel P Castellanos, Chris Woolley, Kelly Amanda Bruno...
https://pubmed.ncbi.nlm.nih.gov/32371500