Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
NCT ID: NCT07079930
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2025-11-30
2027-02-28
Brief Summary
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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.
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Detailed Description
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Preclinical studies demonstrated that D-Serine reduced the psilocybin-induced head-twitch response (HTR) in rodent models and enhanced the expression of synaptic plasticity markers (e.g., GAP43, PSD95, SV2A, synaptophysin) across multiple brain regions, with effects sustained up to 12 days post-treatment. These findings suggest that the combination may improve the safety and tolerability of psilocybin, particularly for populations sensitive to its psychoactive effects.
The trial will consist of four sequential components:
Screening Phase - to assess eligibility.
Preparation Phase - to establish therapeutic rapport and baseline assessments.
Administration Phase - involving a single oral administration of the investigational combination (psilocybin + D-Serine).
Follow-up Phase - including in-person follow-up visits on Day 2, Day 7, Day 28, and Day 84 post-treatment to monitor safety outcomes, subjective responses, and potential delayed effects.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
First cohort of 5 participants will be recruited and administered a single dose of 15 mg of Psilocybin and 5 gr of D-Serine. Safety data will be collected, and an interim safety report will be submitted to the Ethics Committee (EC).
Following administration to the initial cohort, safety and tolerability will be evaluated, and if no significant concerns are identified, the second cohort will be enrolled to receive a higher dose in order to determine the optimal dosage
The second cohort of 5 participants will receive an increased one time dose of 25 mg of Psilocybin and 7 gr of D-Serine to determine the effective dose.
The following visits will be conducted for both cohorts: Screening, Preparation, Administration (Day 1), and follow-up visits on Day 2, Day 7, Day 28, and Day 84.
TREATMENT
NONE
Study Groups
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15 mg of Psilocybin and 5 gr of D-Serine
The investigational drug, 15 mg of Psilocybin and 5 g of D-Serine, will be administered as a single oral dose in solution form.
Psilocybin and D-Serine
A single administration of the drug, with dosage divided as follows:
Cohort 1: 15 mg of Psilocybin and 5 gr of D-Serine Cohort 2: 25 mg of Psilocybin and 7 gr of D-Serine
Physical Examination
The physical examination will include diagnosis and documentation of any significant clinical abnormalities or diseases. It will be performed during the baseline rating visit (preparation phase).
Vital signs
Vital sign measurements (blood pressure, pulse, and oxygen saturation) will be taken at screening, preparation, baseline rating, administration day, day 2, day 28, and day 84.
Vital signs will be assessed at the following time points on the administration day and on day 2: pre-administration, and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours post-administration.
ECG test
A 12-lead ECG will be performed to rule out underlying cardiac abnormalities. An ECG will be conducted for each patient during the screening and Day 2 visits.
Comprehensive Blood Panel
A comprehensive blood panel will be performed to assess kidney and liver function, electrolyte balance, and glucose levels.
It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Complete Blood Count
Complete Blood Count will be performed to check for hematological abnormalities.
It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Urinalysis
Urinalysis will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Urine Toxicology Screen
Urine Toxicology Screen will be performed to rule out illicit drug use. It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
A pregnancy Urine test
A urine pregnancy test will be performed for women of childbearing potential only. It will be conducted during the screening and baseline rating visits. If the urine test is positive, a serum β-hCG test will be performed for confirmation.
Electroencephalogram
EEG will be performed during the baseline rating scale and Day 7 visits to evaluate brain activity
Plasma Amino Acid Levels
The following blood test parameters - D-Serine, L-Serine, and Glycine - will be assessed during the Screening and Day 28 visits.
Plasma Inflammation Markers
The following blood test parameters - Tumor Necrosis Factor Alpha (TNF-α), Interleukin-6 (IL-6), and C-Reactive Protein (CRP) - will be assessed during the Screening and Day 28 visits.
Plasma Brain-Derived Neurotrophic Facto
Plasma BDNF (Brain-Derived Neurotrophic Factor) levels will be measured during the screening and Day 28 visits.
Mini International Neuropsychiatric Interview
The Mini International Neuropsychiatric Interview (MINI) will be administered during the screening visit to rule out any current or past major psychiatric disorders.
Family Psychiatric History Assessment
The Family Psychiatric History Assessment (FPHA) will be administered during the screening visit to help rule out any current or past major psychiatric disorders.
Beck Depression Inventory
The Beck Depression Inventory (BDI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to assess baseline mood and to rule out depressive symptoms.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to screen for anxiety disorders.
Profile of Mood States
The Profile of Mood States (POMS) will be administered to assess baseline mood and emotional state.
It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.
On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.
Subjective Units of Distress Scale
Subjective Units of Distress Scale (SUDS) will be administered to assess anxiety and stress levels.
It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.
On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.
Five-Dimensional Altered States of Consciousness questionnaire
The Five-Dimensional Altered States of Consciousness questionnaire (5D-ASC) will be used to assess the acute subjective psychedelic experience. It will be administered after the acute effects have subsided - at 6.0 hours post-administration on the administration day, and again on day 2 - to evaluate five key experiential dimensions: visual restructuralization, oceanic boundlessness, reduction of vigilance, anxious ego dissolution, and auditory alterations. Each item will be rated using a Visual Analogue Scale (VAS) ranging from "NO, not more than usually" (0 mm) to "YES, much more than usually" (100 mm).
Integration
The integration process is conducted to support participants in processing and incorporating their therapeutic experience into daily life, with the aim of enhancing emotional insight and psychological well-being. Integration will take place at the following visits: 8.0 hours post-treatment on the administration day, day 2, day 7, day 28, and day 84.
25 mg of Psilocybin and 7 gr of D-Serine
The investigational drug, 25 mg of Psilocybin and 7 g of D-Serine, will be administered as a single oral dose in solution form.
Psilocybin and D-Serine
A single administration of the drug, with dosage divided as follows:
Cohort 1: 15 mg of Psilocybin and 5 gr of D-Serine Cohort 2: 25 mg of Psilocybin and 7 gr of D-Serine
Physical Examination
The physical examination will include diagnosis and documentation of any significant clinical abnormalities or diseases. It will be performed during the baseline rating visit (preparation phase).
Vital signs
Vital sign measurements (blood pressure, pulse, and oxygen saturation) will be taken at screening, preparation, baseline rating, administration day, day 2, day 28, and day 84.
Vital signs will be assessed at the following time points on the administration day and on day 2: pre-administration, and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours post-administration.
ECG test
A 12-lead ECG will be performed to rule out underlying cardiac abnormalities. An ECG will be conducted for each patient during the screening and Day 2 visits.
Comprehensive Blood Panel
A comprehensive blood panel will be performed to assess kidney and liver function, electrolyte balance, and glucose levels.
It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Complete Blood Count
Complete Blood Count will be performed to check for hematological abnormalities.
It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Urinalysis
Urinalysis will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Urine Toxicology Screen
Urine Toxicology Screen will be performed to rule out illicit drug use. It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
A pregnancy Urine test
A urine pregnancy test will be performed for women of childbearing potential only. It will be conducted during the screening and baseline rating visits. If the urine test is positive, a serum β-hCG test will be performed for confirmation.
Electroencephalogram
EEG will be performed during the baseline rating scale and Day 7 visits to evaluate brain activity
Plasma Amino Acid Levels
The following blood test parameters - D-Serine, L-Serine, and Glycine - will be assessed during the Screening and Day 28 visits.
Plasma Inflammation Markers
The following blood test parameters - Tumor Necrosis Factor Alpha (TNF-α), Interleukin-6 (IL-6), and C-Reactive Protein (CRP) - will be assessed during the Screening and Day 28 visits.
Plasma Brain-Derived Neurotrophic Facto
Plasma BDNF (Brain-Derived Neurotrophic Factor) levels will be measured during the screening and Day 28 visits.
Mini International Neuropsychiatric Interview
The Mini International Neuropsychiatric Interview (MINI) will be administered during the screening visit to rule out any current or past major psychiatric disorders.
Family Psychiatric History Assessment
The Family Psychiatric History Assessment (FPHA) will be administered during the screening visit to help rule out any current or past major psychiatric disorders.
Beck Depression Inventory
The Beck Depression Inventory (BDI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to assess baseline mood and to rule out depressive symptoms.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to screen for anxiety disorders.
Profile of Mood States
The Profile of Mood States (POMS) will be administered to assess baseline mood and emotional state.
It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.
On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.
Subjective Units of Distress Scale
Subjective Units of Distress Scale (SUDS) will be administered to assess anxiety and stress levels.
It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.
On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.
Five-Dimensional Altered States of Consciousness questionnaire
The Five-Dimensional Altered States of Consciousness questionnaire (5D-ASC) will be used to assess the acute subjective psychedelic experience. It will be administered after the acute effects have subsided - at 6.0 hours post-administration on the administration day, and again on day 2 - to evaluate five key experiential dimensions: visual restructuralization, oceanic boundlessness, reduction of vigilance, anxious ego dissolution, and auditory alterations. Each item will be rated using a Visual Analogue Scale (VAS) ranging from "NO, not more than usually" (0 mm) to "YES, much more than usually" (100 mm).
Integration
The integration process is conducted to support participants in processing and incorporating their therapeutic experience into daily life, with the aim of enhancing emotional insight and psychological well-being. Integration will take place at the following visits: 8.0 hours post-treatment on the administration day, day 2, day 7, day 28, and day 84.
Interventions
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Psilocybin and D-Serine
A single administration of the drug, with dosage divided as follows:
Cohort 1: 15 mg of Psilocybin and 5 gr of D-Serine Cohort 2: 25 mg of Psilocybin and 7 gr of D-Serine
Physical Examination
The physical examination will include diagnosis and documentation of any significant clinical abnormalities or diseases. It will be performed during the baseline rating visit (preparation phase).
Vital signs
Vital sign measurements (blood pressure, pulse, and oxygen saturation) will be taken at screening, preparation, baseline rating, administration day, day 2, day 28, and day 84.
Vital signs will be assessed at the following time points on the administration day and on day 2: pre-administration, and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours post-administration.
ECG test
A 12-lead ECG will be performed to rule out underlying cardiac abnormalities. An ECG will be conducted for each patient during the screening and Day 2 visits.
Comprehensive Blood Panel
A comprehensive blood panel will be performed to assess kidney and liver function, electrolyte balance, and glucose levels.
It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Complete Blood Count
Complete Blood Count will be performed to check for hematological abnormalities.
It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Urinalysis
Urinalysis will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
Urine Toxicology Screen
Urine Toxicology Screen will be performed to rule out illicit drug use. It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.
A pregnancy Urine test
A urine pregnancy test will be performed for women of childbearing potential only. It will be conducted during the screening and baseline rating visits. If the urine test is positive, a serum β-hCG test will be performed for confirmation.
Electroencephalogram
EEG will be performed during the baseline rating scale and Day 7 visits to evaluate brain activity
Plasma Amino Acid Levels
The following blood test parameters - D-Serine, L-Serine, and Glycine - will be assessed during the Screening and Day 28 visits.
Plasma Inflammation Markers
The following blood test parameters - Tumor Necrosis Factor Alpha (TNF-α), Interleukin-6 (IL-6), and C-Reactive Protein (CRP) - will be assessed during the Screening and Day 28 visits.
Plasma Brain-Derived Neurotrophic Facto
Plasma BDNF (Brain-Derived Neurotrophic Factor) levels will be measured during the screening and Day 28 visits.
Mini International Neuropsychiatric Interview
The Mini International Neuropsychiatric Interview (MINI) will be administered during the screening visit to rule out any current or past major psychiatric disorders.
Family Psychiatric History Assessment
The Family Psychiatric History Assessment (FPHA) will be administered during the screening visit to help rule out any current or past major psychiatric disorders.
Beck Depression Inventory
The Beck Depression Inventory (BDI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to assess baseline mood and to rule out depressive symptoms.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to screen for anxiety disorders.
Profile of Mood States
The Profile of Mood States (POMS) will be administered to assess baseline mood and emotional state.
It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.
On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.
Subjective Units of Distress Scale
Subjective Units of Distress Scale (SUDS) will be administered to assess anxiety and stress levels.
It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.
On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.
Five-Dimensional Altered States of Consciousness questionnaire
The Five-Dimensional Altered States of Consciousness questionnaire (5D-ASC) will be used to assess the acute subjective psychedelic experience. It will be administered after the acute effects have subsided - at 6.0 hours post-administration on the administration day, and again on day 2 - to evaluate five key experiential dimensions: visual restructuralization, oceanic boundlessness, reduction of vigilance, anxious ego dissolution, and auditory alterations. Each item will be rated using a Visual Analogue Scale (VAS) ranging from "NO, not more than usually" (0 mm) to "YES, much more than usually" (100 mm).
Integration
The integration process is conducted to support participants in processing and incorporating their therapeutic experience into daily life, with the aim of enhancing emotional insight and psychological well-being. Integration will take place at the following visits: 8.0 hours post-treatment on the administration day, day 2, day 7, day 28, and day 84.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Medically healthy, as confirmed by a comprehensive clinical assessment.
3. Written informed consent provided.
Exclusion Criteria
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.
25 Years
60 Years
ALL
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Locations
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Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ps-PD-24-01-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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