2 x 2 Factorial, Double-blind, Randomized Trial of 'Set and Setting': a Translational Study in Healthy Volunteers
Robin Carhart-Harris, PhD, MA
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).
Description
Recent research posits that psychedelic medicine is best employed as a combination treatment, i.e., as drug x psychological support or psychotherapy referred to for simplicity as 'psychedelic therapy'. It is assumed that positive outcomes via psychedelic therapy critically depend on a synergistic relationship between drug-induced brain and mind plasticity and supportive contextual factors (Carhart-Harris et al., 2018; Carhart-Harris and Friston, 2019). These contextual factors have been referred to as 'set and setting' (Leary et al., 1963) or 'extrapharmacological'- highlighting elements beyon…
Eligibility
- Age range
- 21–70 years
- Sex
- All
- Healthy volunteers
- Yes
If you are interested in participating in this study, please follow this link to check your eligibility: https://tiny.ucsf.edu/setsettingscreener Inclusion Criteria: Participants will be considered for inclusion if they: 1. Are between 21 and 70 years of age 2. Are fluent in speaking and reading English 3. Are able to swallow pills/capsules 4. If able to become pregnant, must be non-lactating, have a negative pregnancy test at study entry and prior to each Experimental Session and must agree to an adequate form of birth control over the course of the study. Adequate forms of birth control i…
Interventions
- DrugPsilocybin
Healthy participants will receive up to 25 mg psilocybin.
- BehavioralContext 1
Drug administration will take place in a context (Context 1) that is expected to modulate acute and post-acute drug effects.
- BehavioralContext 2
Drug administration will take place in a context (Context 2) that is expected to modulate acute and post-acute drug effects.
- DrugPlacebo
Healthy participants will receive an inactive placebo.
Location
- UCSF Mission BaySan Francisco, California