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Tests treatment safety and results for Healthy Volunteers
Official title Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
ClinicalTrials.gov ID: NCT07079930
What this study is testing
What is Psilocybin and D-Serine?
Psilocybin and D-Serine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Aged 25-60 years, male or female.
- Medically healthy, as confirmed by a comprehensive clinical assessment.
- Written informed consent provided.
You likely can't join if
- History of any Axis 1 psychiatric disorder requiring pharmacotherapy such as schizophrenia, schizoaffective disorder, any other psychotic disorder...
- Family history (among first-degree relatives) of schizophrenia, bipolar disorder, or other psychotic disorder
- History of cardiovascular disorders.
- Pregnant or breastfeeding women or women of childbearing age not using effective contraception.
- Use of psilocybin or other psychedelic compound in the 12 months preceding the study
- Use of medications that interact with psilocybin or D-Serine.
See the full eligibility criteria
- Aged 25-60 years, male or female.
- Medically healthy, as confirmed by a comprehensive clinical assessment.
- Written informed consent provided.
- 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...
- Family history (among first-degree relatives) of schizophrenia, bipolar disorder, or other psychotic disorder
- History of cardiovascular disorders.
- Pregnant or breastfeeding women or women of childbearing age not using effective contraception.
- Use of psilocybin or other psychedelic compound in the 12 months preceding the study
- Use of medications that interact with psilocybin or D-Serine.
- Positive urinary drug screening.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.