Psilocybin Administration With 5-HT1a Blockade
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-60
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
21 - 60 years old
Must give written or electronic informed consent
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Pindolol
DrugPindolol 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
DrugMicrocrystalline cellulose capsules, identical in appearance to the active treatment, containing no pharmacologically active ingredients, will be administered as an inert placebo comparator.
Psilocybin
DrugPsilocybin 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.
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: Psilocybin co-administered with placeboPlacebo comparator 2 interventions
Group B: Psilocybin co-administered with pindololExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Mystical Experiences Questionnaire
Assess changes in intensity of the subjective effects induced by psilocybin with co-administration of a 5-HT1A antagonist, pindolol as measured through the mystical experience questionnaire. Scores can range from 0-150 with a higher score indicating a more intense mystical-type experience.
Time frame
From the first dosing session to the end of the second dosing session, approximately 10 daysSecondary outcomes
1
Change in alpha power (Spectral Power)
Assess changes in neural measures of drug intensity acutely using EEG, specifically global change in alpha power.
Time frame
From the first dosing session to the end of the second dosing session, approximately 10 daysSponsors and contacts
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Source ClinicalTrials.gov