Early phase 1: testing Pindolol for Psychedelic Effects in Healthy Volunteers
This study wants 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.
Official registry: https://clinicaltrials.gov/study/NCT07565493 · Johns Hopkins University · enrollment listed as 18
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Pindolol, Placebo, or Psilocybin. The registry lists allocation as randomized. This study wants 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).
They plan to enroll about 18 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Psilocybin Administration With 5-HT1a Blockade
Interventions: Pindolol, Placebo, Psilocybin
Primary outcome (registry wording): Mystical Experiences Questionnaire
Who it is for (from inclusion criteria)
- Ages 21 Years to 60 Years
- Must have at least a high-school level of education or equivalent (e.g. GED) and are fluent in English
- Must be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- Must agree not to take any as needed (PRN) medications on the mornings of drug sessions
- Must agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration
- Must agree to refrain from using all psychoactive substances within 24 hours or 5 elimination half-lives (whichever is greater) before psilocybin administration. Caffeine is the exception
- Must have a negative urine toxicology report on the same day as drug dosing
- Who are male and sexually active, must agree to use contraception and refrain from sperm donation within 90 days of completing dosing sessions. Effective methods of contraception are barrier, hormonal, and sterilization methods
Who the registry excludes
- Are currently taking a medication with any significant pharmacokinetic or pharmacodynamic interactions with pindolol (e.g. beta-blockers or other anti-hypertensive medications)
- Have a history of orthostatic hypotension or low blood-pressure
- Have elevated transaminases (2x the upper limit of normal)
- Have a Child-Pugh score that falls within classes B or C
- Are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing
- Have epilepsy or a history of seizures
- Have insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Public study contact (from the registry)
Zarmeen Zahid, PhD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Center for Psychedelics and Consciousness Research — Baltimore, Maryland (recruiting)
FAQ about this NCT record
Is NCT07565493 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07565493?
Early phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07565493?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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