NCT07079930 Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
| NCT ID | NCT07079930 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hadassah Medical Organization |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-12-11 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 25-60 years, male or female. 2. Medically healthy, as confirmed by a comprehensive clinical assessment. 3. Written informed consent provided. Exclusion Criteria: 1. History of any Axis 1 psychiatric disorder requiring pharmacotherapy such as schizophrenia, schizoaffective disorder, any other psychotic disorder, bipolar disorder, as well as non-psychotic disorders such as generalized anxiety disorder, major depressive disorder, obsessive-compulsive disorder, posttraumatic stress disorder. 2. Family history (among first-degree relatives) of schizophrenia, bipolar disorder, or other psychotic disorder 3. History of cardiovascular disorders. 4. Pregnant or breastfeeding women or women of childbearing age not using effective contraception. 5. Use of psilocybin or other psychedelic compound in the 12 months preceding the study 6. Use of medications that interact with psilocybin or D-Serine. 7. Positive urinary drug screening.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07079930 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 60 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07079930 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07079930 currently recruiting?
Yes, NCT07079930 is actively recruiting participants. Contact the research team at lerer@mail.huji.ac.il for enrollment information.
Where is the NCT07079930 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT07079930 clinical trial?
NCT07079930 is sponsored by Hadassah Medical Organization. The trial plans to enroll 10 participants.