Healthy
Conditions
Keywords
Psilocybin, Psilocin, Psilocybin Therapy, Psychedelics, Healthy, San Francisco
Brief summary
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.
Detailed description
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.
Interventions
DRUGPsilocin
17.5mg oral psilocin with psychological support and physiological monitoring
DRUGPsilocybin
25mg oral psilocybin with psychological support and physiological monitoring
DRUGSublingual Psilocin
2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring
Sponsors
Filament Health Corp.
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological Effects | Baseline to 8 hours following drug delivery | blood pressure |
| Psychological Effects | Baseline to 4 weeks after drug delivery | \- Peak psychedelic intensity ratings will be measured using Likert scale (0-10 rating scale, 0=not intense at all, 10=highest intensity imaginable) |
| Adverse Effects | Baseline to 24 hours after dosing session | * Acute hypertension, hypotension, tachycardia, or bradycardia will be detected through blood pressure and heart rate monitoring at 10 minutes prior to drug administration and measured frequently up to 360 minutes following administration * Other dosing-related side effects including descriptive reports of nausea, headaches, dizziness, weakness, drowsiness, paresthesia, or blurred vision will be assessed during check-ins, after dosing effects have waned, and 24 hours following dosing |
Countries
United States
Outcome results
None listed