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Healthy Participants With Lower-than-average Mental Well-beingPsychedelicsHealthy volunteersBehavioralDrugBehavioralPhase 2

What this study is

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).

What's being tested

  • Psilocybin

    Intervention · DRUG

    Healthy participants will receive up to 25 mg psilocybin.

  • Context 1

    Intervention · BEHAVIORAL

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

  • Context 2

    Intervention · BEHAVIORAL

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

  • Placebo

    Intervention · DRUG

    Healthy participants will receive an inactive placebo.

Study details

Official title
2 x 2 Factorial, Double-blind, Randomized Trial of 'Set and Setting': a Translational Study in Healthy Volunteers
Sponsor
Robin Carhart-Harris, PhD, MA
Conditions
Healthy Participants With Lower-than-average Mental Well-being
Enrolling
120 people
Starts
2024-10-20
Est. completion
2028-11-30
Design
Double-blind, randomized, factorial, Phase 2
Record
View on ClinicalTrials.gov ↗