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Psilocybin Administration With 5-HT1a Blockade

NCT07565493 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Psychedelic Effects in Healthy Volunteers

Interventions

DRUG

Pindolol

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.

DRUG

Placebo

Microcrystalline cellulose capsules, identical in appearance to the active treatment, containing no pharmacologically active ingredients, will be administered as an inert placebo comparator.

DRUG

Psilocybin

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.

Sponsors & Collaborators

Principal Investigators

  • Sandeep M Nayak, MD · Center for Psychedelics and Consciousness Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-06-15
Completion
2028-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07565493 on ClinicalTrials.gov