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Home/Research/Psilocybin/Safety & Risk Management

Psilocybin for Safety & Risk Management

112 papers and 16 clinical trials exploring psilocybin as a treatment for safety & risk management.

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
IndicationMental health disorders affect over 900 million people worldwide, with conditions like PTSD and depression being among the most prevalent.

Safety & Risk Management

Safety and risk management in psychedelic therapy remains a critical area of research, necessitating vigilant assessment of potential adverse effects as clinical usage expands. Current efforts focus on ensuring that therapeutic practices minimise harm while maximising efficacy for a range of conditions.

Full Safety & Risk Management profile

Academic Research

112 papers
Open Accessindividual

Real-World Psilocybin Therapy for Treatment-Resistant Depression: a Retrospective Observational Study

In a retrospective case series (n=19) of treatment‑resistant depression patients treated with psilocybin (20–35 mg) in routine clinical practice, depressive symptoms decreased significantly with large effect sizes on MADRS and BDI, though response and remission rates were lower than in controlled trials and no additive benefit of multiple doses was found.

Published
June 1, 2026
Journal
The Lancet Regional Health – Europe
Authors
Jungwirth, J., Westenhöfer, S., Aicher, H., Provaznikova, B., Kronenberg, G., Seifritz, E., Prinz, S., Olbrich, S.
Open Accessindividual

Psilocybin-induced neurocardiogenic syncope: a case report

This case report describes a healthy 35-year-old man who fainted after taking 25 mg oral psilocybin during an open-label brain function study, with low blood pressure, rapid heartbeat and sweating consistent with neurocardiogenic syncope. He recovered quickly with simple supportive care, highlighting a rare hypotensive reaction during psilocybin administration.

Published
May 28, 2026
Journal
Psychopharmacology
Authors
Atiq, M. A., Weisman, E., Guerra, R. B., Martinez, L. L., Yaden, D. B., Barrett, F. S., Nayak, S., Sayali, C.
Open Accessindividual

Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: The EPISODE Randomized Clinical Trial

In this triple‑blind, active placebo‑controlled randomised trial (n=144) of adults with treatment‑resistant depression, two 25 mg doses of psilocybin plus adjunct psychotherapy produced clinically meaningful reductions in depressive symptoms on exploratory secondary measures but did not significantly improve the pre‑second‑dose HAMD17 response rate versus nicotinamide.

Published
March 18, 2026
Journal
JAMA Psychiatry
Authors
Mertens, L. J., Koslowski, M., Betzler, F., Brand, M., Evens, R., Kärtner, L., Jungaberle, A., Jungaberle, H., Majić, T., Schmitz, C. N., Ströhle, A., Scharf, D., Spangemacher, M., Wolff, M., Assadi, Z., Bahri, S., Becher, L., Färber, L. V., Kirchen, N., Kulakova, E., Kunz, L., Meijer, A., Rohrmoser, B., Wellek, S., Berger, M. M., Gründer, G.
Paywallindividual

A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive–compulsive disorder

This randomised clinical trial (n=15) found that psilocybin (up to 21mg/70kg) given over up to eight weekly sessions was well-tolerated with no serious adverse events, and significantly reduced OCD symptoms compared to placebo, with 73% of participants responding and 40% reaching remission by the end of the 8-week treatment, with meaningful effects still present at 6 months.

Published
March 13, 2026
Journal
Journal of Psychopharmacology
Authors
Moreno, F. A., Allen, K. E., Wiegand, C. B., Dunne, R., Prickett, J. I., Bayze, B., Allen, J. J. B.
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 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.

Clinical Trials

16 trials
RecruitingPhase I

Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers

This Phase I, open-label, dose-escalation trial (n=10) will evaluate the safety and psychological effects of a combined psilocybin and D-Serine formulation; cohort 1 will receive psilocybin 15 mg with D-Serine 5 g, and if safe cohort 2 will receive psilocybin 25 mg with D-Serine 7 g.

Started
November 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07079930
Not yet recruitingPhase I

A Phase 1, Open-label, Pilot Study to Assess the Safety, Feasibility and Initial Efficacy of IV infused Psilocin (TRP-8803) Administration in Concert with Psychotherapy Among Adult Patients with Binge Eating Disorder (BED)

This Phase I open-label trial (n=12) will investigate the safety, feasibility, and initial efficacy of intravenous psilocin (TRP-8803), administered in two doses (ranging from 6.7 mg to 15 mg) two weeks apart, paired with psychedelic-assisted psychotherapy for adults with binge eating disorder (BED).

Started
June 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12625000330448p
RecruitingPhase I/II

Psilocybin-Assisted Therapy for Physician Well-Being and Burnout

Open-label single-group study (n=10) assessing feasibility, safety, and preliminary efficacy of a single 25 mg oral psilocybin dose with preparatory and integration therapy for UCSD physicians with burnout.

Started
April 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06814522
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
RecruitingPhase I

Safety for Home Administration of Microdose Psilocybin Use

This single-blind interventional trial (n=20) will investigate the safety of ascending doses of psilocybin for home administration.

Started
August 1, 2024
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT06450210
CompletedPhase I

A study in healthy male volunteers to investigate how the test medicine COMP360 [14C]-psilocybin is taken up, broken down and removed from the body

This Phase I, open-label trial (n=6) investigates how psilocybin (COMP360; 10mg) is absorbed, distributed, metabolised, and excreted in healthy male volunteers aged 30-55.

Started
July 18, 2024
Type
interventional
Blinding
none
Randomized
No
Registry ID
ISRCTN37167117

Explore further

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