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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

21 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• Psilocybin — DRUG
  Healthy participants will receive up to 25 mg psilocybin.
• Context 1 — BEHAVIORAL
  Drug administration will take place in a context (Context 1) that is expected to modulate acute and post-acute drug effects.
• Context 2 — BEHAVIORAL
  Drug administration will take place in a context (Context 2) that is expected to modulate acute and post-acute drug effects.
• Placebo — DRUG
  Healthy participants will receive an inactive placebo.

Study Details

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).

Key Dates

Start date

Oct 20, 2024

Status verified

Jun 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Psilocybin C1
  Following screening and a baseline assessment visit, healthy volunteers will receive one dose of up to 25mg psilocybin in a context (Context 1) that is hypothesized to modulate acute and post-acute drug effects.
• Experimental: Psilocybin C2
  Following screening and a baseline assessment visit, healthy volunteers will receive one dose of up to 25mg psilocybin in a context (Context 2) that is hypothesized to modulate acute and post-acute drug effects.
• Placebo Comparator: Placebo C1
  Following screening and a baseline assessment visit, healthy volunteers will receive one dose of an inactive placebo in a context (Context 1) that is hypothesized to modulate acute and post-acute drug effects.
• Placebo Comparator: Placebo C2
  Following screening and a baseline assessment visit, healthy volunteers will receive one dose of an inactive placebo in a context (Context 2) that is hypothesized to modulate acute and post-acute drug effects.

Primary Outcome Measure

Challenging Experience Questionnaire (CEQ) subscales score [ Time Frame: Eight hours post-dose. ]

Central Contacts

• Hannes Kettner, MSc
  4158495452
  [email protected]
• Avery Ostrand, MSc
  [email protected]

Locations (1)

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