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

Placebo for Palliative & End-of-Life Distress

3 papers and 17 clinical trials exploring placebo as a treatment for palliative & end-of-life distress.

CompoundComparator / Control

Placebo

Placebo is the most widely referenced comparator in psychedelic clinical research, appearing in over 500 trials. Understanding how placebos are designed, administered, and interpreted is essential to evaluating the evidence base for psychedelic-assisted therapies — and one of the field’s most contested methodological challenges.

Full Placebo 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

3 papers
Open Accessindividual

It's all about the relationship: The caregiver experience of supporting a person with advanced cancer going through an LSD microdosing trial

This secondary analysis of an RCT (n=15 interviews) found that caregivers of people with advanced cancer were generally supportive of participation in an LSD microdosing plus meaning-centred psychotherapy trial, though some were initially hesitant. It highlighted the bidirectional nature of patient-caregiver well-being, with the intervention seen as offering hope, easing existential distress, and strengthening their relationship.

Published
February 26, 2026
Journal
Palliative & Supportive Care
Authors
Cottam, F., Wells, A., Clayden, C., Reynolds, L.
Open Accessindividual

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

This double-blind, randomised, placebo-controlled Phase I study (n=48) evaluates the safety, pharmacokinetics, and psychoactive effects of RE104 (psilocybin analog; Luvesilocin; a prodrug of 4-OH-DiPT) in healthy adults with prior psychedelic experience. RE104 was well tolerated up to 40 mg with no serious adverse events, and plasma levels of its active form correlated with subjective drug effect and mystical experience scores. The compound produced psilocybin-like effects with a shorter duration (3-4 hours), supporting further therapeutic investigation.

Published
July 21, 2025
Journal
Journal of Clinical Psychopharmacology
Authors
Ludbrook, G., Bryson, N., Taylor, B., Hocevar-Trnka, J., Johnson, M. W., Hirman, J., Morrish, G., Alexander, R., Pollack, M.
Open Accessindividual

DMT models the near-death experience

This within-subjects, placebo-controlled study (n=13) found that the DMT experience had many overlaps with the near-death experience (NDE).

Published
August 15, 2018
Journal
Frontiers in Psychology
Authors
Timmermann, C., Roseman, L., Williams, L., Erritzoe, D., Martial, C., Cassol, H., Laureys, S., Nutt, D. J., Carhart-Harris, R. L.

Clinical Trials

17 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
RecruitingPhase II

Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Randomized, double-blind, parallel Phase II trial (n=30) testing psilocybin-assisted psychotherapy (25 mg, two sessions) versus niacin placebo for depression and/or anxiety in patients with advanced cancer.

Started
June 30, 2024
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06200155
RecruitingPhase II

A double-blind, randomised trial of methylphenidate-assisted versus MDMA-assisted therapy for mood and anxiety symptoms in advanced-stage cancer patients

This double-blind, randomised, parallel Phase II trial (n=32) compares single-dose MDMA-assisted therapy (120 mg, optional 60 mg supplemental) versus methylphenidate-assisted therapy (20 mg, optional 10 mg supplemental) for depressive and anxiety symptoms in people with advanced-stage cancer.

Started
July 31, 2023
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
ACTRN12619001334190
Active not recruitingPhase II

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

This Phase II, single-center trial (n=56) investigates the efficacy, safety, and tolerability of up to two doses of psilocybin (25mg) administered at an interval of 9 to 10 weeks in patients with Major Depressive Disorder (MDD) and cancer.

Started
July 7, 2023
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05947383
Not yet recruitingPhase II

A feasibility study of Psychedelic Microdosing-Assisted Meaning Centred Psychotherapy in advanced stage cancer patients (PAM Trial)

This double-blind, placebo-controlled feasibility trial (n=40) investigates Psychedelic Microdosing-Assisted Meaning-Centred Psychotherapy (PA–MCP) in advanced-stage cancer patients. Led by Dr Lisa Reynolds at The University of Auckland, the study evaluates LSD microdosing (starting at 8 µg, twice weekly for 6 weeks; 13 doses total) alongside Meaning-Centred Psychotherapy.

Started
June 1, 2023
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
ACTRN12623000478617

Explore further

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