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Home/Research/Psilocybin/Chronic Pain

Psilocybin for Chronic Pain

59 papers and 29 clinical trials exploring psilocybin as a treatment for chronic pain.

CompoundClassic Psychedelic

Psilocybin

Psilocybin is a naturally occurring tryptamine psychedelic that acts as a prodrug to psilocin, a potent 5-HT2A receptor agonist. It is the furthest advanced psychedelic in clinical development, with two positive Phase III trials in treatment-resistant depression and expanding regulated access in Australia, Germany, and US states.

Full Psilocybin profile
IndicationOver 1.5 billion worldwide.

Chronic Pain

Chronic pain is increasingly recognised as a multifaceted condition that may respond to psychedelic therapies, which are gaining attention in clinical settings for their potential efficacy in pain management. Recent research indicates that compounds such as psilocybin and MDMA are entering clinical trials aimed at exploring their therapeutic effects on chronic pain syndromes.

Full Chronic Pain profile

Academic Research

59 papers
Open Accessindividual

Psychedelic-assisted therapy: a survey on the clinical methods of Swiss physicians

This survey study (n=41) examined how Swiss physicians provide psychedelic-assisted therapy under legal exemptions, mainly for depression, anxiety, PTSD and chronic pain. It found wide variation in practice, with psilocybin, MDMA and LSD commonly used, music often played during sessions, and adverse effects usually including disorientation, feeling cold, anxiety and nausea.

Published
May 20, 2026
Journal
Therapeutic Advances in Psychopharmacology
Authors
Beichmann, K., Catzeflis, P., Aicher, H. D., Seragnoli, F., Calder, A., Amrani, A., Hasler, G.
Open Accessindividual

Pilot study of psilocybin in patients with post-treatment lyme disease

In an open‑label, single‑arm pilot study of 20 patients with post‑treatment Lyme disease, two psilocybin sessions with psychological support produced significant, sustained reductions in symptom burden (40% decrease in GSQ‑30 at six months) and improvements in both physical and mental quality of life. The intervention was feasible and well-tolerated with no serious related adverse events, supporting further controlled trials of psilocybin‑assisted therapy for PTLD.

Published
February 25, 2026
Journal
Scientific Reports
Authors
Garcia-Romeu, A., Naudé, G. P., Rebman, A. W., So, S., Yaffe, A., Geithner, I., Kozero, E. A., Yang, T., Soloski, M. J., Aucott, J. N.
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

Comparing single- and repeat-dose psilocybin with active placebo for migraine prevention in an exploratory randomized controlled clinical trial

In an exploratory randomised, double‑blind trial in adults with frequent migraine, single or two‑dose psilocybin produced reductions in migraine frequency similar to an active diphenhydramine placebo and no serious adverse events were observed. Incomplete blinding and nonsignificant between‑group differences despite large effect sizes in psilocybin arms indicate the need for larger, better‑controlled trials with headache‑specialist input to separate drug and non‑drug effects.

Published
December 29, 2025
Journal
Headache
Authors
Schindler, E. A. D., Gottschalk, C. H., Pittman, B. P., D'Souza, D. C.
Open Accessindividual

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial

In an open‑label Phase IIa trial (n-12), a single 10 mg intranasal dose of 5‑MeO‑DMT (BPL‑003) given alongside a 10‑week relapse‑prevention CBT programme was acceptable in safety and tolerability in people with moderate–severe alcohol use disorder. Over 12 weeks, participants showed large improvements in drinking (mean abstinent days rose from 33.2% to 80.8% and heavy drinking days fell from 56.2% to 13.2%), providing preliminary evidence of efficacy and supporting larger controlled trials.

Published
December 10, 2025
Journal
Addiction
Authors
Marsden, J., Kelleher, M., Dunbar, F., Ermakova, A. O., Mitcheson, L., Roberts, C., Rucker, J. J., Scott, G., Saeger, I., Small, F., Seynaeve, M.
Open Accessindividual

Psilocybin-assisted psychotherapy for methamphetamine use disorder: A pilot open-label safety and feasibility study

In a single‑arm, open‑label pilot of 15 people with methamphetamine use disorder, outpatient psilocybin‑assisted psychotherapy (single 25 mg oral dose with preparatory and integration sessions) was feasible and well tolerated with no serious adverse events, and was associated with reductions in self‑reported methamphetamine use and craving at 28 and 90 days; a larger randomised trial is required to confirm efficacy and safety.

Published
September 20, 2025
Journal
Addiction
Authors
Knock, E., Siefried, K. J., Gill Bedi, |., Albert, S., Day, R. O., Ezard, N., Ross, M., Liknaitzky, P., Brett, J., Bedi, G.

Clinical Trials

29 trials
Not yet recruitingPhase II

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

This Phase II, randomised, open-label, parallel trial (n=83) will assess whether prophylactic psilocybin prevents or mitigates chemotherapy-induced peripheral neuropathy (CIPN) in adults receiving adjuvant neurotoxic chemotherapy (taxanes or platinum agents) for breast, colorectal, or head and neck cancers; the primary outcome is the proportion of participants with a ≥25% worsening from baseline to Week 12 on the EORTC QLQ-CIPN20 sensory subscale. Participants are randomised to one of three arms: Arm A receives supervised oral psilocybin 25 mg given as four doses (two pre-chemotherapy doses one week apart on Day 7 and Day 14, then two monthly doses prior to chemotherapy cycles 2 and 3 on Day 42 and Day 70); Arm B receives subperceptual oral psilocybin 1mg administered every other day during a two-week pre-chemotherapy run-in (mailed as 7×1 mg capsules in tamper-evident packaging) with dosing continued prior to the first three cycles (total 21 doses); Arm C receives standard of care with no study drug. The primary analysis compares 25 mg versus pooled control (standard of care plus 1 mg), tested two-sided at α=0.05 with confirmatory pairwise tests (25 mg vs SOC; 25 mg vs 1 mg) using Hochberg adjustment if significant. Key secondary objectives include rates of chemotherapy dose modifications for neurotoxicity, NCI-CTCAE measures of CIPN, and effects on quality of life and psychosocial outcomes assessed with instruments such as PROMIS-10, PROMIS-A, PROMIS-D, FACT-Cog, PSQI, BFI, MDASI, MEQ30 and the Flourishing scale. Eligible participants are adults (≥18 years) with ECOG 0–2, no pre-existing peripheral neuropathy greater than Grade 1, and scheduled for relevant chemotherapy; safety and adverse events are followed through study completion (average 1 year).

Started
May 4, 2026
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT07227909
RecruitingPhase I/II

Psilocybin to Treat Depression in Spinal Cord Injury

This Phase I/Phase II, non-randomised, triple‑masked, sequential trial (n=30) will evaluate the safety and tolerability of oral psilocybin (5 mg, 10 mg and 25 mg) in veterans with chronic spinal cord injury and a diagnosed depressive disorder. The primary focus is to determine whether psilocybin increases the number or severity of treatment‑related adverse events (recorded in an adverse events log) over the study period, with secondary assessment of tolerability of the psychedelic experience and effects on depression severity, pain, muscle spasms, autonomic measures and quality of life. Thirty participants (15 with paraplegia and 15 with tetraplegia) will be allocated to one of three dose cohorts (low 5 mg, medium 10 mg, high 25 mg) in a stepwise safety design; participants will be masked to dose. Enrolment covers up to 13 months and includes at least 16 study visits (including seven visits comprising psilocybin‑assisted therapy), in‑person visits at the VA medical centre and remote visits, and follow‑up assessments through study completion. Key eligibility requirements include age ≥22 years, chronic spinal cord injury ≥1 year, weight ≥50 kg, ability to swallow pills and to taper antidepressants under clinician supervision; major exclusions include recent psychedelic, ketamine or ECT exposure, Bipolar I disorder, certain substance use disorders, uncontrolled hypertension and pregnancy or nursing.

Started
January 1, 2026
Type
interventional
Blinding
triple
Randomized
No
Registry ID
NCT07251491
Not yet recruitingPhase I

A Phase 1, Open-label, Single-arm Basket Trial of the Intravenously Administered Psilocin (TRP-8803): Safety, Anxiety, and Quality of Life Across Health Conditions Characterised by Cognitive Inflexibility, Emotional Distress, and Persistent Bodily Symptom Burden

This Phase 1, open‑label, single‑arm basket trial (N=66) tests the safety and early clinical effects of intravenous psilocin (TRP‑8803) administered in two dosing sessions alongside psychotherapy over a 6‑week treatment period, with a 12‑week follow‑up. Conducted in Australia and sponsored by Tryp Therapeutics, the study enrols participants across ten diagnostic cohorts — anorexia nervosa, body dysmorphic disorder, chronic fatigue, fibromyalgia, generalised anxiety disorder, irritable bowel syndrome, long COVID, major depressive disorder, obsessive–compulsive disorder and post‑traumatic stress disorder — to evaluate tolerability and signals of benefit in anxiety and quality of life. As a Phase 1 trial the primary outcomes focus on safety and tolerability (adverse events, vital signs and treatment‑emergent effects), with secondary or exploratory outcomes assessing changes in anxiety symptoms and health‑related quality of life using standardised, validated instruments. The single‑arm, open‑label design means there is no placebo or active comparator, and efficacy assessments are intended to generate preliminary, hypothesis‑generating data to inform the design of subsequent controlled studies. The study began recruitment in November 2025.

Started
November 3, 2025
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
ACTRN12625000949482
Not yet recruitingPhase I

Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study

This open-label Phase I trial (n=15) will assess the feasibility and safety of a single 25 mg dose of pharmaceutical-grade psilocybin combined with psychotherapy in women aged 18–45 with chronic pelvic pain (CPP) who have not responded to at least one conventional treatment.

Started
August 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06988319
Enrolling by invitationPhase I

Psilocybin With Intracranial Neural Sensing (PINS)

Open-label, single-arm Phase I pilot (n=20) assessing a single 10 mg oral dose of psilocybin in adults with chronic pain who have implanted sensing-capable DBS devices; neural, sensory, and cognitive effects measured.

Started
May 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06919640
Not yet recruitingPhase II

Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids

Phase II, single-group supportive-care study (n=20) of low-dose oral psilocybin (source: Psilocybe mexicana) given twice weekly for 4 weeks (8 doses) with preparatory and integration psychotherapy in cancer patients with chronic opioid-treated pain.

Started
March 3, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06827054

Explore further

Search all Psilocybin papers Search all Chronic Pain trials Full Psilocybin profile Full Chronic Pain profile