Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07610135
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Healthy
  • Mood
  • Mood (Psychological Function)
  • Well Being

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin — DRUG
    Psilocybin, 25 mg, oral, single dose
  • Pimavanserin — DRUG
    Pimavanserin, 34 mg, oral, two doses
  • Inactive Placebo — DRUG
    Inactive placebo, oral, two doses

Study Details

Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration. The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Psilocybin + Pimavanserin
    Two oral pretreatment doses of pimavanserin (34 mg each) followed by a single oral dose of psilocybin (25 mg)
  • Placebo Comparator: Psilocybin + Placebo
    Two oral pretreatment doses of inactive placebo followed by a single oral dose of psilocybin (25 mg)

Primary Outcome Measure

Persisting Effects Questionnaire (PEQ) score [ Time Frame: Day 7, Day 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMaryland21224
Arozo Azimi
[email protected]
410-550-0007
Mazen A Atiq, MD
[email protected]
David B. Yaden, PhD (PRINCIPAL_INVESTIGATOR)
Mazen Atiq, MD (SUB_INVESTIGATOR)

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By research site
Johns Hopkins Center for Psychedelic and Consciousness Research· Baltimore, MD

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