Assessment of the tolerance and safety of Prescription of different doses of Psilocybin in Healthy adults.

Assessment of the tolerability and safety of Administration of different doses of Psilocybin in Healthy adults.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-37qx63d

Enrollment

Unknown

Registered

2024-02-17

Start date

2024-05-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

This is an open phase I clinical study of dose escalation involving 18 normal patients aged between 21 and 65 years to evaluate the tolerance and safety of the drug under investigation Psilocybin BTP2

E05.940.481

Eligibility

Age

21 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adults without comorbidities aged between 21 and 65 years from both gender

Exclusion criteria

Exclusion criteria: Participants who meet any of the following exclusion criteria are not eligible for the study including use of medications that may interfere with the study drug, history of heart, liver, kidney disease, history of cancer or organ transplant, insulin dependent diabetes or uncontrolled diabetes, gastrointestinal disease that may interfere with the absorption of the substance orally, current or past history of psychiatric disorders as schizophrenia, psychotic disorder, bipolar disorder, personality disorder, first degree family history of psychiatric disorders, seizures or fainting, creatinine elevation, nicotine dependence that would prevent an individual from being nicotine-free for 7 to 10 hours during the dosing period, women who are pregnant or intending to become pregnant during the study or who are currently breastfeeding, chemical dependency or abuse of alcohol or illicit drugs in the last 12 months, platelets disorders, clinically significant anemia, liver injury

Design outcomes

Primary

Measure	Time frame
We hope to evaluate general tolerance to the drug in 18 healthy volunteers who will receive staggered doses of the drug, evaluating the acute and subacute effects of the substance through monitoring and standardized recording of adverse events and through the application of the 5DASC questionnaire, Five Dimensional Altered State of Consciousness, to assess the intensity of the psychedelic experience	—

Measure

Time frame

We hope to evaluate general tolerance to the drug in 18 healthy volunteers who will receive staggered doses of the drug, evaluating the acute and subacute effects of the substance through monitoring and standardized recording of adverse events and through the application of the 5DASC questionnaire, Five Dimensional Altered State of Consciousness, to assess the intensity of the psychedelic experience

—

Secondary

Measure	Time frame
We hope to find insights in volunteers quality of life by analyzing their general quality of life and sleep after the dosing session with the application of the MSQ, Mini Sleep Questionnaire and EQ5D, Quality Questionnaire. of life.	—

Countries

Brazil

Contacts

Public ContactCesar Segre

Biocase Brasil

cesar@biocasebrasil.com.br+5511976333207

Outcome results

None listed

Source: REBEC (via WHO ICTRP)