Psilocybin Administration With 5-HT1a Blockade

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07565493
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Psychedelic Effects in Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Pindolol — DRUG
    Pindolol is a 5-HT1A antagonist drug that will be used as a pharmacological probe for the mechanism of acute subjective effects in the altered state of consciousness induced by psilocybin.
  • Placebo — DRUG
    Microcrystalline cellulose capsules, identical in appearance to the active treatment, containing no pharmacologically active ingredients, will be administered as an inert placebo comparator.
  • Psilocybin — DRUG
    Psilocybin is a tryptamine psychedelic with 5-HT2A agonist activity. The psilocybin-induced altered state of consciousness is characterized by changes in sensory perception, cognition, and induction of mystical-type experiences. These subjective effects will be assessed in each dosing session.

Study Details

The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries.

Key Dates

Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Jun 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Psilocybin co-administered with placebo
    Psilocybin will be co-administered with microcrystalline cellulose placebo.
  • Experimental: Psilocybin co-administered with pindolol
    Psilocybin will be co-administered with 5-HT1A antagonist pindolol.

Primary Outcome Measure

Mystical Experiences Questionnaire [ Time Frame: From the first dosing session to the end of the second dosing session, approximately 10 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Psychedelics and Consciousness ResearchBaltimoreMaryland21224-5010
Zarmeen Zahid, PhD
[email protected]
667-208-8099
Sandeep M Nayak, MD (PRINCIPAL_INVESTIGATOR)
Zarmeen Zahid, PhD (SUB_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
Center for Psychedelics and Consciousness Research· Baltimore, MD

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