Psilocybin for Healthy Volunteers

57 papers and 67 clinical trials exploring psilocybin as a treatment for healthy volunteers.

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.

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IndicationApproximately 300 million people affected by depression worldwide.

Healthy Volunteers

Research involving healthy volunteers has expanded to investigate the therapeutic potentials of various psychedelics for mental health conditions. Recent findings, emphasizing compounds like psilocybin and DMT, illustrate a promising future for psychedelic-assisted therapies.

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Academic Research

57 papers
Open Accessindividual

A novel psychedelic 5-HT2A receptor agonist GM-2505: The pharmacokinetic, safety, and pharmacodynamic profile from a randomized trial healthy volunteer

In a randomized, placebo‑controlled ascending‑dose study in 48 healthy volunteers, single IV doses of GM‑2505 up to 20 mg were well tolerated and showed dose‑proportional pharmacokinetics (t1/2 40–50 min) with dose‑dependent neuroendocrine, neurophysiological and subjective psychedelic effects, including decreased theta/alpha and increased gamma EEG power. The duration of cardiovascular and subjective effects was intermediate between psilocybin and DMT, indicating a practical 10–15 mg IV dose range for supervised clinical use.

Published
Journal
Journal of Psychopharmacology
Authors
Austin, E. W., Borghans, L. G. J. M., Christian, E. P., Dvorak, D., Hughes, Z. A., Jacobs, G., Juachon, M. J., Klein, A. K., Krol, F. J., Kruegel, A. C., Leong, W., Makai-Bölöni, S., Marek, G. J., Otto, M. E., Raines, S., Sporn, J., Umbricht, D., van der Graaf, A. J., Winters, J.
Open Accessindividual

Psilocybin’s effect on human brain synaptic plasticity

A single psilocybin dose increased frontal and hippocampal synaptic density in healthy participants one week after dosing, measured with [11C]UCB-J PET targeting synaptic vesicle glycoprotein 2A (SV2A). Participants dosed in a therapeutic-like room showed stronger mystical-type experiences, longer-lasting psychological benefits and greater synaptic increases than those dosed inside an MRI scanner, indicating that psilocybin’s neuroplastic effects are modulated by environmental context.

Published
Journal
Research Square
Authors
Beliveau, V., Fisher, P. M., Geisler, M., Johansen, A., Lehel, S., Lund, A., Madsen, M. K., McCulloch, D. E-W., Messel, C., Nasser, A., Ozenne, B., Plavén-Sigray, P., Søndergaard, A., Stenbæk, D. S., Svarer, C., Vassilieva, A.
Open Accessindividual

Molecular, haemodynamic, and functional effects of LSD in the human brain

Using simultaneous PET–MRI in healthy volunteers, this first integrated molecular and functional neuroimaging study quantifies LSD occupancy at cerebral serotonin 2A receptors and establishes a dose–occupancy relationship while revealing an anticlockwise hysteresis between plasma levels and subjective effects. LSD produced distinct haemodynamic and functional changes — increasing global cerebral and internal carotid artery flow without altering artery diameter and reducing global connectivity (GCOR), with GCOR changes negatively correlated with CBF and differing from effects of psilocybin — findings relevant to clinical development.

Published
Journal
MedRvix
Authors
Andersen, T. L., Falck, N., Fisher, P. M., Geisler, M., Holze, F., Jensen, P. S., Johansen, A., Johansen, S. S., Knudsen, G. M., Larsen, K., McCulloch, D. E-W., Neufeld, V., Nielsen, M. K. K., Nykjær, C. H., Randrup, P. P., Reveles Jensen, K. H., Shulganov, V., Skov-Andersen, P., Spanggård, A., Steenstrup, E., Stenbæk, D. S., Svarer, C.
Open Accessindividual

The phenomenology of psilocybin's experience mediates subsequent persistent psychological effects independently of sex, previous experience, or setting

Repeated administration of psilocybin in healthy adults produced persistent positive psychological effects, and the acute phenomenology—particularly Oceanic Boundlessness, Visionary Restructuralization and peak experiences ending in a positive mood—predicted these long-term benefits independently of sex, prior psychedelic experience, setting or repeat dosing. Challenging or mixed acute experiences in the controlled laboratory did not produce lasting negative outcomes, supporting psilocybin’s psychological safety for repeated use in clinical trials.

Published
Journal
Pharmacological Reports
Authors
Andrashko, V., Androvičová, R., Balíková, M., Bravermanová, A., Brunovský, M., Hájková, K., Horáček, J., Klučková, T., Korčák, J., Kuchař, M., Nikolič, M., Páleníček, T., Tylš, F., Vejmola, C., Viktorin, V., Viktorinová, M., Zach, P.

Clinical Trials

67 trials

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