Actively Recruiting
Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
Led by Hadassah Medical Organization · Updated on 2026-02-05
10
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this open-label, dose-escalation, prospective study is to evaluate the safety and psychological effects of a Psilocybin and D-Serine formulation in healthy volunteers. The main objectives are: 1. To assess the psychological and physiological effects of psilocybin administered with D-Serine in healthy adults. 2. To determine whether D-Serine modulates or attenuates the psychedelic effects of psilocybin. 3. To evaluate the safety and tolerability of psilocybin and D-Serine co-administration. Study population includes: 10 healthy male or female volunteers aged 25-60 years with no history of psychiatric or major medical disorders and no current evidence of such disorders. The study includes two cohorts. The first cohort of 5 participants will receive 15 mg of Psilocybin and 5 g of D-Serine. Safety data will be collected and submitted in an interim report to the Ethics Committee. If no safety concerns arise, the second cohort will receive an increased dose of 25 mg of Psilocybin and 7 g of D-Serine to help determine the optimal dose for a future Phase IIa clinical trial.
CONDITIONS
Official Title
Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 25-60 years, male or female
- Medically healthy based on comprehensive clinical assessment
- Provided written informed consent
You will not qualify if you...
- History of major psychiatric disorders requiring medication, including schizophrenia, bipolar disorder, other psychotic disorders, generalized anxiety disorder, major depression, OCD, or PTSD
- Family history of schizophrenia, bipolar disorder, or other psychotic disorders in first-degree relatives
- History of cardiovascular disease
- Pregnant, breastfeeding, or women of childbearing age not using effective contraception
- Use of psilocybin or other psychedelic drugs within 12 months prior to study
- Use of medications that interact with psilocybin or D-Serine
- Positive drug screening by urine test
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Actively Recruiting
Research Team
B
Bernard Lerer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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