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Home/Research/Psilocybin/Healthy Volunteers

Psilocybin for Healthy Volunteers

156 papers and 74 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.

Full Psilocybin profile
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.

Full Healthy Volunteers profile

Academic Research

156 papers
Open Accessmeta

A systematic review of the pharmacokinetics of classical serotonergic psychedelic compounds in healthy adult subjects

This systematic review (s=32) of healthy adult volunteers examined the pharmacokinetics of LSD, psilocybin, DMT, mescaline and 5-MeO-DMT. It found that LSD and psilocybin showed dose-related peak levels, while oral and intravenous DMT differed in ways that may matter clinically.

Published
May 29, 2026
Journal
Journal of Psychopharmacology
Authors
Hampsey, E., Martin, K., Kalfas, M., Benson, L., Wihlborg, S., Jelen, L., Young, A. H., Rucker, J.
Open Accessindividual

Blinding integrity in psychedelic research: Evidence from a comparative randomized controlled trial of psilocybin, MDMA, and methylphenidate in healthy volunteers

This double-blind randomised controlled trial (n=120) in healthy volunteers assessed how well blinding held when people received psilocybin, MDMA, or methylphenidate as an active placebo, and found blinding was generally insufficient. Functional unblinding was highest for psilocybin, moderate for MDMA, and lowest for methylphenidate.

Published
May 28, 2026
Journal
European Neuropsychopharmacology
Authors
Belinger, L., Rieser, N., Engeli, E., Becciolini, L., Clamote, M., Pribis, M., Saissi, F., Florineth, G., Hehl, N., Herdener, M., Preller, K.
Open Accessindividual

Human brain changes after first psilocybin use

In a placebo-controlled, within-subject neuroimaging study of 28 psychedelic‑naive participants, a single high (25mg) dose of psilocybin produced lasting functional and anatomical brain changes from 1 hour to 1 month and improved cognitive flexibility, psychological insight and well‑being at one month. Diffusion MRI showed decreased axial diffusivity in prefrontal–subcortical tracts that correlated with reduced brain network modularity (which correlated with improved well‑being), acute increases in cortical signal entropy predicted one‑month well‑being via next‑day psychological insight, and none of these effects were seen with a 1 mg control dose.

Published
May 5, 2026
Journal
Nature Communications
Authors
Lyons, T., Spriggs, M. J., Kerkelä, L., Rosas, F. E., Roseman, L., Mediano, P. A. M., Timmermann, C., Oestreich, L., Pagni, B. A., Zeifman, R. J., Hampshire, A. D. G., Trender, W., Douglass, H., Girn, M., Godfrey, K., Kettner, H., Sharif, F., Espasiano, L., Gazzaley, A., Wall, M. B., Erritzoe, D., Nutt, D. J., Carhart-Harris, R. L.
Open Accessindividual

Acute dose-dependent effects of 4-bromo-2,5-dimethoxyphenethylamine (2C-B) compared with 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin in a double-blind, placebo-controlled study in healthy participants

This double-blind, randomised, placebo-controlled crossover study (n=24) in healthy adults compared acute effects of 2C-B, MDMA and psilocybin. A 30 mg dose of 2C-B produced effects similar to MDMA and some psychedelic changes, while MDMA caused the strongest cardiovascular stimulation and psilocybin caused more anxiety and unpleasant effects.

Published
April 28, 2026
Journal
Neuropsychopharmacology
Authors
Arikci, D., Borgulya, J., Straumann, I., Vizeli, P., Luethi, D., Thomann, J., Rudin, D., Vukalovic, I., Eckert, A., Liechti, M. E., Holze, F.
Open Accessindividual

Mystical dynamics: renewal, luminous light, and ego disintegration as key features associated with mystical oneness—a psychometric analysis using the PES100 in controlled psychedelic studies

This psychometric analysis using the PES100 examined 816 measurements from healthy participants (n=386) across 15 controlled psychedelic studies of LSD, psilocybin, mescaline and DMT. It found that mystical oneness was strongly linked to feelings of luminous light and renewal, and moderately to strongly linked to ego disintegration, with these links increasing with dose.

Published
March 31, 2026
Journal
Religion, Brain & Behavior
Authors
Stocker, K., Hartmann, M., Barrett, F. S., Richards, W., Sepeda, N. D., Straumann, I., Klaiber, A., Vogt, S. B., Erne, L., Ley, L., Becker, A. M., Vizeli, P., Holze, F., Liechti, M. E.
Open Accessmeta

Psilocybin shapes the slow, global propagation of brain activity over the cortical layout of 5HT2a receptors

This brain imaging analysis (n=7) used fMRI data from sessions with psilocybin and a methylphenidate (Ritalin) control to explore how psychedelics affect the speed at which activity travels across the cortex. It found that faster propagation was linked to increased functional connectivity and that the distribution of 5-HT2a receptors may help explain how psilocybin modulates these travelling waves.

Published
March 26, 2026
Journal
Communications Biology
Authors
Mäki-Marttunen, V.

Clinical Trials

74 trials
Not yet recruitingPhase I

The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.

This Phase I, randomized, triple-blind, parallel-group trial (n=50) will study the effects of a single 25 mg oral dose of psilocybin versus placebo in healthy adult volunteers aged 21–65, with the primary aim of characterising biological, psychological and high-density EEG (hd-EEG) biomarkers and related safety/tolerability following one-time administration. Participants will be randomised to receive either psilocybin 25 mg (one tablet by mouth) or a matching inactive placebo; the psilocybin is supplied by Filament Health (Burnaby, British Columbia). Key eligibility includes ages 21–65, BMI 18–34 kg/m2, no current or past substance use disorder, limited prior psychedelic exposure (never or at most one prior classic serotonergic psychedelic experience more than 5 years earlier), and contraception/pregnancy requirements for women of childbearing potential. Primary biochemical outcomes measured from baseline to 7 days post-dose include 2 AG (pmol/mL), 2 OG (pmol/mL), AEA (pmol/mL), OEA (pmol/mL), PEA (pmol/mL), Trp (μg/mL), Kyn (ng/mL), Kyn/Trp*1000 and 5 HT (ng/mL); psychological and hd-EEG measures will also be assessed. The study is scheduled to start 2026-09-01 with estimated completion 2029-09-01.

Started
September 1, 2026
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07433452
Not yet recruitingPhase I

Psilocybin Administration With 5-HT1a Blockade

This early Phase I, randomised, triple-blind, crossover trial (n=18) will evaluate whether 5-HT1A receptor blockade alters the acute subjective effects of psilocybin in healthy volunteers. Participants will receive psilocybin with either pindolol or placebo, with the study focused on subjective survey outcomes, acute electroencephalography (EEG), and the mechanistic basis of the altered state of consciousness induced by psilocybin. In each dosing session, participants will be given a moderate dose of psilocybin trihydrate 18 mg (equivalent to 15 mg psilocybin anhydrate) together with pindolol 30 mg or a microcrystalline cellulose placebo. The study will also examine post-acute sleep and dreaming using sleep EEG, sleep diaries, and dream diaries, collected for 10 days before and 10 days after each drug administration session, alongside at-home sleep EEG recordings for 5 days before and 5 days after each session. The primary outcome is the Mystical Experiences Questionnaire, assessed from the first dosing session to the end of the second dosing session, over approximately 10 days.

Started
June 15, 2026
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07565493
Not yet recruitingPhase I

Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study

This Phase I, randomised, double‑blind, parallel trial (n=120) will evaluate whether intravenous psilocybin improves wellbeing when administered while awake versus while asleep, and whether psilocybin given during sleep differs from saline placebo, in healthy adults aged 18–45 with sub‑optimal self‑reported wellbeing. The primary outcome is change in Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS) score from baseline (Day 0) to post‑dosing Day 29. Participants are randomised to one of three overnight dosing arms: psilocybin while awake with saline while asleep; saline while awake with psilocybin while asleep; or saline while awake with saline while asleep. Psilocybin is given intravenously as an infusion of 3.2 mg over 10 minutes followed by 0.8 mg over the next 20 minutes; placebo is 20 mL saline drawn into a 30 mL syringe. All participants receive 0.2 mg oral clonidine 60 minutes prior to the initial infusion to support sleep. Key secondary outcomes include psychological flexibility, social connectedness and measures of wellbeing, life satisfaction, purpose and meaning ascribed to the intervention, and participants can expect to be on study for up to 4 months.

Started
April 1, 2026
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT07360301
RecruitingPhase I

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

This Phase I, single-group trial (n=40) will assess the safety and tolerability of oral psilocybin in healthy older adults aged 65 to 85 years. It will evaluate two dose cohorts, with the main aim of determining whether psilocybin can be administered safely in this population and how it is tolerated over time. Participants will receive two escalating oral doses of psilocybin 30 days apart: Cohort 1a will receive 10 mg followed by 25 mg, and Cohort 1b will receive 15 mg followed by 30 mg. The study will also examine pharmacokinetics, patient-reported outcomes such as psychedelic experience and wellbeing, and relationships between drug exposure, safety findings, and reported effects. Safety outcomes include adverse events assessed for up to 14 weeks.

Started
April 1, 2026
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07516405
Not yet recruitingPhase I

A Study of Psychedelics in Healthy Older Adults With Low Well-being

This Phase I, randomised, triple-blind trial (n=80) will assess the safety, feasibility, and mechanisms of psilocybin and dextromethorphan in healthy older adults aged 50 to 90 years with low well-being. The study aims to evaluate whether psilocybin can acutely increase the complexity of EEG activity and longitudinally decrease plasma markers of neuroinflammation, while also exploring changes in autonomic physiology and brain structure and function over time. Participants will be assigned to one of four experimental arms, receiving either a low-to-moderate (5-10 mg) or moderate-to-high (25-30 mg) dose of psilocybin, or a low-to-moderate (30-60 mg) or moderate-to-high (80-90 mg) dose of dextromethorphan. The trial will involve up to 3 months of participation, including 3 to 4 in-person visits and 3 to 4 remote visits, with the dosing visit lasting between 8 to 12 hours. Primary outcomes will focus on acute changes in EEG-based measures two hours post-dose.

Started
March 1, 2026
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07386730
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

Explore further

Search all Psilocybin papers Search all Healthy Volunteers trials Full Psilocybin profile Full Healthy Volunteers profile