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Home/Research/Psilocybin/Equity and Ethics

Psilocybin for Equity and Ethics

38 papers and 2 clinical trials exploring psilocybin as a treatment for equity and ethics.

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 1 in 4 adults experience mental health disorders annually worldwide.

Equity and Ethics

Equity and ethics in psychedelic research is a vital and complex topic, addressing the need for fair access and representation in clinical trials, as well as the stewardship of traditional knowledge. The involvement of Indigenous communities, who have historically used these substances, must be safeguarded against exploitation as the field matures.

Full Equity and Ethics profile

Academic Research

38 papers
Open Accessindividual

A Virtual Clinical Trial of Psychedelics to Treat Patients With Disorders of Consciousness

Using individualised whole‑brain computational modelling fitted to fMRI and diffusion MRI, the authors simulated administration of LSD and psilocybin and applied in silico perturbations to compare states of consciousness and assess treatment effects in disorders of consciousness. Simulated psychedelics shifted patients' brain dynamics closer to criticality—especially in the minimally conscious state—with responses in UWS linked to structural connectivity and in MCS to baseline functional connectivity, providing a computational rationale for psychedelic therapies and personalised prediction.

Published
November 20, 2025
Journal
Advanced Science
Authors
Alnagger, N. L., Cardone, P., Martial, C., Perl, Y. S., Mindlin, I., Sitt, J. D., Roseman, L., Carhart‐Harris, R., Nutt, D., Mallaroni, P., Mason, N., Ramaekers, J. G., Bonhomme, V., Laureys, S., Deco, G., Gosseries, O., Núñez, P., Annen, J.
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

Set and setting in psilocybin-assisted therapy: A qualitative study of patients with cancer and depression

This qualitative study (n=28 interviews) of participants in a psilocybin-assisted therapy trial for cancer-related depression found that therapeutic benefits were closely tied to participants' ability to surrender (accepting and remaining open to the experience's intensity and unpredictability), with a safe, supportive, and ethical environment critical to fostering trust and engagement, and preparation and integration key to maximizing benefit, whilst music played a significant but variable role and ceremonial elements added meaning for many despite the clinical setting providing safety.

Published
November 1, 2025
Journal
General Hospital Psychiatry
Authors
Beaussant, Y., Tarbi, E., Nigam, K. B., Miner, S., Sager, Z., Sanders, J. J., Ljuslin, M., Guérin, B., Sholevar, R., Roddy, K., Tulsky, J., Agrawal, M.
Open Accessindividual

Participant experiences of therapeutic touch in psilocybin-assisted therapy

In a longitudinal qualitative study of 18 participants in a psilocybin-assisted therapy trial for generalized anxiety disorder, most participants valued therapeutic touch—particularly after first-hand experience during dosing sessions—reporting it fostered connection, helped manage acute psychedelic intensity and was sometimes experienced as directly therapeutic. Responses were diverse, however, and participants emphasised the need for a strong therapeutic relationship, individualised use within comprehensive consent, and further research on safety and therapist training.

Published
March 26, 2025
Journal
Brain and Behavior
Authors
Ham, R., Gardner, J., Carter, A., Liknaitzky, P.
Open Accessindividual

Compass Psychological Support Model for COMP360 Psilocybin Treatment of Serious Mental Health Conditions

This article describes the Compass Psychological Support Model (CPSM) used to support participants with treatment-resistant depression undergoing investigational psilocybin treatment. The CPSM aims to ensure a safe and meaningful psychedelic experience, complemented by therapist training, mentoring, and fidelity assessment to maintain delivery quality and consistency.

Published
January 1, 2025
Journal
American Journal of Psychiatry
Authors
Kirlic, N., Lennard-Jones, M., Atli, M., Malievskaia, E., Modlin, N. L., Peck, S. K., Gaillard, R., Goodwin, G. M., Koelpin, D.
Paywallmeta

Adverse Events in Studies of Classic Psychedelics: A Systematic Review and Meta-Analysis

This systematic review and meta‑analysis of 214 studies (3,504 participants with analysable adverse‑event data) found that high‑dose classic psychedelics were generally well tolerated in clinical/research settings, with serious adverse events occurring mainly in ~4% of participants who had preexisting neuropsychiatric disorders and no reports in contemporary trials of suicide, persistent psychotic disorder or hallucinogen‑persisting perception disorder. Common non‑serious adverse events (headache, anxiety, nausea, fatigue, dizziness) had similar prevalences for psilocybin and LSD, but substantial heterogeneity and limited systematic adverse‑event monitoring across studies highlight the need for improved pharmacovigilance.

Published
December 1, 2024
Journal
JAMA Psychiatry
Authors
Hinkle, J. T., Graziosi, M., Nayak, S., Yaden, D. B.

Clinical Trials

2 trials
CompletedPhase NA

Low-Income Group Psilocybin Assisted Therapy for Depression (LIGPATD)

Open-label, single-group feasibility study (n=20) evaluating group psilocybin-assisted therapy (two psilocybin sessions) for low-income adults with major depression in Oregon.

Started
August 1, 2024
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06372197
Not yet recruitingPhase I

Pilot study of administration of psilocybin in healthy volunteers within a marae

This interventional trial (n=12) will assess the feasibility and acceptability of administering a single 25 mg oral dose of psilocybin to healthy Māori volunteers in a marae setting under clinical supervision (open-label, single-group, Phase I).

Started
August 1, 2024
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12624000869572

Explore further

Search all Psilocybin papers Search all Equity and Ethics trials Full Psilocybin profile Full Equity and Ethics profile