Psilocybin with D-Serine: safety and psychological effects in healthy adults
Official title: Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
Run by Hadassah Medical Organization · NCT07079930 · Data updated 2026-11-12
This study will test whether combining psilocybin with D-Serine is safe and how it changes psychological and physiological responses in healthy adults aged 25–60.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Status | Recruiting |
| Started | December 11, 2025 |
| Main results expected | November 2026 |
| Study ends | February 2027 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07079930 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy men and women aged 25–60 with no major medical or psychiatric disorders, not pregnant or breastfeeding, and not using interacting medications are ideal candidates.
✕Probably not a fit
People with current or past major psychiatric disorders, a family history of psychosis, cardiovascular disease, pregnancy/lactation, recent psychedelic use, positive drug screens, or those on interacting medications would not be eligible and are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, first-in-human Phase 1 study uses a dose-escalation design to characterize safety, tolerability, and initial psychological and physiological responses to a single oral administration of psilocybin co‑administered with D‑Serine in healthy volunteers. Ten participants are enrolled in two sequential cohorts: five will receive 15 mg psilocybin with 5 g D‑Serine and, if interim safety review is favorable, five will receive 25 mg psilocybin with D‑Serine. Participants undergo screening and preparatory sessions, in-person dosing, and structured follow-up visits on Days 2, 7, 28, and 84 to monitor adverse events, vital signs, ECG, lab tests, and subjective effects. The rationale is based on preclinical data suggesting D‑Serine can attenuate acute psychedelic responses while preserving synaptic plasticity markers observed after psilocybin exposure.
Why it matters
Potential benefit: If successful, the combination could make psilocybin administration safer and better tolerated, potentially widening its future therapeutic use.
How similar studies have gone: This is a novel first-in-human combination: preclinical rodent studies showed D‑Serine reduced psilocybin-like behaviors and enhanced synaptic plasticity markers, but human data are not yet available.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel Recruiting
Study contacts
- Study coordinator: Bernard Lerer, MD
- Email: lerer@mail.huji.ac.il
- Phone: +972-50-7874575
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.