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RECRUITING
NCT06626139
PHASE2

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

Sponsor: Robin Carhart-Harris, PhD, MA

View on ClinicalTrials.gov

Summary

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).

Official title: 2 x 2 Factorial, Double-blind, Randomized Trial of 'Set and Setting': a Translational Study in Healthy Volunteers

Key Details

Gender

All

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-10-20

Completion Date

2028-11-30

Last Updated

2025-03-27

Healthy Volunteers

Yes

Interventions

DRUG

Psilocybin

Healthy participants will receive up to 25 mg psilocybin.

BEHAVIORAL

Context 1

Drug administration will take place in a context (Context 1) that is expected to modulate acute and post-acute drug effects.

BEHAVIORAL

Context 2

Drug administration will take place in a context (Context 2) that is expected to modulate acute and post-acute drug effects.

DRUG

Placebo

Healthy participants will receive an inactive placebo.

Locations (1)

UCSF Mission Bay

San Francisco, California, United States