Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2025-07-31

Brief Summary

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To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults.

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Detailed Description

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The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oral & Sublingual Psilocin, & Oral Psilocybin

Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.

Group Type ACTIVE_COMPARATOR

Psilocin

Intervention Type DRUG

17.5mg oral psilocin with psychological support and physiological monitoring

Psilocybin

Intervention Type DRUG

25mg oral psilocybin with psychological support and physiological monitoring

Sublingual Psilocin

Intervention Type DRUG

2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring

Sublingual Psilocin

Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time.

Group Type ACTIVE_COMPARATOR

Sublingual Psilocin

Intervention Type DRUG

2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring

Interventions

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Psilocin

17.5mg oral psilocin with psychological support and physiological monitoring

Intervention Type DRUG

Psilocybin

25mg oral psilocybin with psychological support and physiological monitoring

Intervention Type DRUG

Sublingual Psilocin

2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 25 to 50
* Comfortable speaking and writing in English
* Commit to attending all study visits and remote data collection tasks
* No planned surgeries during the study
* Had at least one prior experience with a psychedelic substance
* Generally mentally and physically healthy
* Agree to abstain from THC, CBD, or nicotine products during study

Exclusion Criteria

* Participated in another clinical trial within 30 days of entry to this trial
* Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants
* A health condition that makes study unsafe or unfeasible, determined by study physicians

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes