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Home/Research/Psilocybin/Palliative & End-of-Life Distress

Psilocybin for Palliative & End-of-Life Distress

87 papers and 32 clinical trials exploring psilocybin as a treatment for palliative & end-of-life distress.

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
IndicationApproximately 40% of patients with terminal illnesses report significant distress at the end of life.

Palliative & End-of-Life Distress

Palliative and end-of-life distress represents a significant psychosocial challenge faced by patients with life-limiting illnesses, significantly impacting quality of life. Recent research suggests that psychedelic compounds, particularly psilocybin, may offer promising therapeutic benefits in alleviating existential distress and improving psychological well-being in these patients.

Full Palliative & End-of-Life Distress profile

Academic Research

87 papers
Open Accessindividual

Evaluation of a facilitator training program in a randomized controlled trial of psilocybin treatment for depression

This secondary analysis of an RCT (n=9 facilitators) evaluated a 15-week online and on-site training programme for nurses acting as facilitators in a psilocybin treatment trial for depression. The training improved some role-play communication skills, but the gains were modest, and most nurses still felt they needed more practical in-person preparation.

Published
April 9, 2026
Journal
BMC Medical Education
Authors
Morel, N. S., Stenbaek, D. S., Lundberg, J., Beckman, M.
Open Accessmeta

Psychedelic medicine: mechanisms, evidence, and translation to practice

This review (2026) summarises the rapidly growing evidence for psychedelic-assisted therapies, finding the strongest support for psilocybin in treatment-resistant depression (TRD) and MDMA in post-traumatic stress disorder (PTSD). It also highlights that while these treatments are generally well tolerated in controlled settings, major challenges remain around unclear mechanisms, trial limitations, scalability, and translation into routine practice.

Published
February 23, 2026
Journal
BMJ
Authors
Jacobs, E., Zahid, Z., Hinkle, J., Nayak, S., Yaden, D. B.
Open Accessindividual

Group Retreat Psilocybin Therapy for People with Metastatic Cancer with Symptoms of Anxiety and Depression: Safety and Efficacy Outcomes of a Phase 1/2 Study

This Phase I/II study (n=52) tested a group retreat model of psilocybin therapy for people with metastatic cancer and anxiety or depression, using 25 mg psilocybin in a 3-day retreat format. No unattended distress episodes occurred, and anxiety and depression scores fell over 28 days.

Published
January 18, 2026
Journal
Psychedelic Medicine
Authors
Back, A. L., McGregor, B. A., Thorn, L. L., Baker, K., Gooley, T., Kaelen, M., Harvey, K., Guy, J. M., Myers, S., Perez, J., Thompson, P., Billingsley, L., Sesnon, C.
Paywallindividual

Group Retreat Psilocybin Therapy for People with Metastatic Cancer with Anxiety and Depression: A Rite of Passage Facilitation Model for a Phase 1/2 Study

This secondary analysis (n=52) describes a Phase I/II group psilocybin retreat model for people with metastatic cancer and moderate to severe anxiety or depression, using a secular ritual approach based on rites of passage. It describes a model designed for a 3-day in-person retreat and linked to safety and efficacy outcomes in the trial.

Published
December 9, 2025
Journal
Psychedelic Medicine
Authors
Back, A. L., McGregor, B. A., Billingsley, L., Blom, D., Callan, G., Myers, S., Guy, J., Kumar, S., Layer, M., Levin, J., Perez, J., Thompson, P., Salmonson, K., Whinney, J., Thorn, L. L.
Paywallindividual

Psilocybin-assisted therapy for demoralisation in hospice patients: feasibility, safety and preliminary efficacy

In an open‑label pilot where 10 hospice patients received a single 25 mg psilocybin‑assisted therapy session, the intervention was feasible and well tolerated with no serious psilocybin‑related adverse events and produced a significant reduction in demoralisation at three weeks (mean reduction 8.8 points, p=0.0196). Acceptability varied because of the intervention’s emotional intensity, indicating PAT can be integrated into hospice care but requires optimisation and larger controlled trials.

Published
November 3, 2025
Journal
BMJ Open
Authors
Beaussant, Y., Sager, Z., Brennan, C., Kristan, I., Ljuslin, M., Mazzola, E., Macdonald, D., Murphy, M. E., Nigam, K., Rinaldi, A. D., Sanders, J., Schaefer, K. G., Sholevar, R., Summer, L., Waliji-Banglawala, A., Yudilevich-Espinoza, S., Tulsky, J. A.
Open Accessindividual

Psilocybin-assisted psychotherapy for depression and anxiety associated with life threatening illness: A phase 2b randomized controlled trial

This double-blind placebo-controlled trial (n=35) found that psilocybin-assisted psychotherapy (25mg) significantly reduced depression and anxiety symptoms in adults with life-threatening illnesses compared to an active placebo (100mg niacin), with benefits sustained at 26 weeks and improvements in spiritual well-being, quality of life, demoralisation, and death anxiety.

Published
September 1, 2025
Journal
General Hospital Psychiatry
Authors
Ross, M. L., Iyer, R., Williams, M. L., Boughey, M., O'callaghan, C., Hiscock, R., Dwyer, J.

Clinical Trials

32 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 III

Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)

Phase III, randomized, quadruple-blind, placebo-controlled parallel-arm RCT (n=120) testing psilocybin microdosing (2–3 mg, 4 days/week for 2 weeks) versus placebo to reduce psychological and existential distress in patients receiving palliative care.

Started
August 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07063862
Not yet recruitingPhase II

Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer (PEARL-C1)

This Phase II open-label trial (n=15) will study the effects of psilocybin (25 mg) administered in the context of Psilocybin-assisted Existential, Attachment and Relational (PEARL) therapy for caregivers of patients with advanced cancer.

Started
July 2, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07048743
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
RecruitingPhase II

Psilocybin Therapy for Psychological Distress in Palliative Patients (PsyPal)

Quadruple-blind, randomised, low-dose controlled Phase II trial (n=108) comparing two escalating psilocybin doses (15 mg then 25 mg) versus two low doses (1 mg) in palliative patients with COPD, ALS, MS, or APD and co-morbid depression.

Started
March 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06782724
RecruitingPhase I

Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed with Advanced Stage Cancer

This open-label, Phase I trial (n=15) will assess the safety and efficacy of psilocybin (25mg) alongside psychotherapy for treating demoralization syndrome in patients with advanced-stage cancer.

Started
March 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06818994

Explore further

Search all Psilocybin papers Search all Palliative & End-of-Life Distress trials Full Psilocybin profile Full Palliative & End-of-Life Distress profile