Study on tolerance and safety of different doses of Magic Mushroom Extract in healthy adults

Evaluation of the tolerability and safety of administering different doses of purified Psilocybin extract in healthy adults

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-2phymmg

Enrollment

Registered

2026-03-30

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

depression Mood Disorder

Interventions

This is an open-label, phase I, dose-escalation clinical study involving 18 normal patients aged 21 to 65 years to evaluate the tolerability and safety of the investigational drug Psilocybin BTP23. Al

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 not eligible for the study are using of antidepressive drugs; have 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 and liver injury

Design outcomes

Primary

Measure	Time frame
we expect to evaluate the overall tolerance to the drug in 18 healthy volunteers who will receive escalating doses of the medication, assessing the acute and subacute effects of the substance through standardized monitoring and recording of adverse events and through the application of the 5DASC questionnaire, altered state of consciousness in five dimensions, to assess the intensity of the psychedelic experience.	—

Measure

Time frame

we expect to evaluate the overall tolerance to the drug in 18 healthy volunteers who will receive escalating doses of the medication, assessing the acute and subacute effects of the substance through standardized monitoring and recording of adverse events and through the application of the 5DASC questionnaire, altered state of consciousness in five dimensions, to assess the intensity of the psychedelic experience.

—

Secondary

Measure	Time frame
We hope to gain insights into the impact on the volunteers' quality of life by analyzing their overall quality of life and sleep quality after the drug administration sessions under investigation, using the MSQ questionnaire, the Mini Sleep Questionnaire, and the EQ5D Quality of Life Questionnaire	—

Countries

Contacts

Public ContactCesar Segre

Biocase Brasil

cesar@biocasebrasil.com.br+5511976333207

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026