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โ† Trials
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Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers

RecruitingPhase 1Ages 25 Years - 60 YearsAllHadassah Medical Organization
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In plain words

What the trial is, and whether it could suit you

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 Committ

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Psilocybin and D-Serine
  • Physical Examination
  • Vital signs
  • ECG test
  • Comprehensive Blood Panel
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Where

1 site
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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