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

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).

Status
recruiting
Phase
Phase 2
Institution
Robin Carhart-Harris, PhD, MA
Principal investigator
Robin Carhart-Harris, PhD
Start date
2024-10-20
End date
2028-11-30
Registry ID
NCT06626139

View trial record

Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.