Comparing the Effects of Psilocin and Psilocybin in Healthy Adults
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05317689
- Lead Sponsor
- University of California, 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oral & Sublingual Psilocin, & Oral Psilocybin Psilocin Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order. Oral & Sublingual Psilocin, & Oral Psilocybin Psilocybin Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order. Oral & Sublingual Psilocin, & Oral Psilocybin Sublingual Psilocin Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order. Sublingual Psilocin Sublingual Psilocin Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time.
- Primary Outcome Measures
Name Time Method Physiological Effects Baseline to 8 hours following drug delivery heart rate
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 dosingPsychological Effects Baseline to 4 weeks after drug delivery - Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States