Investigating the Interaction of Psilocybin and Context of Its Administration in Healthy Volunteers (SnS)

This double-blind, randomised, factorial-design trial (n=120) will investigate the interaction effects between psilocybin (25 mg, oral) and the context of its administration in healthy volunteers with lower-than-average mental well-being.

The study, led by Dr Robin Carhart-Harris at the University of California, San Francisco, will employ a 2×2 factorial design to explore how different contextual factors (‘set and setting’) modulate the acute and post-acute effects of psilocybin.

Participants will be randomly assigned to receive either psilocybin or placebo in one of two distinct environmental conditions. The primary outcomes include changes in psychological well-being, measured by the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS), emotional breakthrough, and the quality of the acute psychedelic experience. Secondary measures will include neuroimaging and electroencephalography (EEG) assessments to examine brain activity patterns. The study is expected to run from October 2024 to November 2028.

Topic Healthy Subjects
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 20 October 2024
End date 30 November 2028
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 120
Sex All
Age 21- 70
Therapy No

Trial Details

One hundred twenty healthy participants, ages 21 to 70, who experience moderate-to-lower-than-average mental well-being will be evenly randomized into four different study arms, using a 2x2 factorial design. Depending on the study arm, participants will either receive an inactive placebo or up to 25mg psilocybin (oral dose), in one of two set and setting conditions; drug administration contexts that are predicted to modulate drug effects. The purpose of this study is to evaluate any interaction effects between an oral dose of psilocybin and the surrounding context (set and setting).

Trial Number NCT06626139

Sponsors & Collaborators

University of California San Francisco
At UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.

Data attribution

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