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

NCT06626139 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-27

No results posted yet for this study

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).

Conditions

  • Healthy Participants With Lower-than-average Mental Well-being

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.

Sponsors & Collaborators

  • Robin Carhart-Harris, PhD, MA

    lead OTHER

Principal Investigators

  • Robin Carhart-Harris, PhD · University of California, San Francisco

  • Jennifer Mitchell, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-20
Primary Completion
2027-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626139 on ClinicalTrials.gov