ClinicalTrials.gg
Sign In
Enrolling by invitationNCT07893912Updated Oct 26, 2026

Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study

An Early Phase 1 interventional study of Ayahuasca in Healthy Adult Participants, sponsored by University of Sao Paulo. Enrolling by invitation at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by University of Sao Paulo · Early Phase 1, Interventional, and Other

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Open-label trial with healthy adults

Read the detailed description

Open-label trial with healthy adults using PET. Our hypothesis is that cortical increases will be observed, particularly in higher-order brain networks, by assessed the cerebral metabolic rate for glucose consumption (CMRglc) with [18F]fluorodeoxyglucose positron emission tomography ([18F]FDG-PET)

02

Conditions studied

  • Healthy Adult Participants
03

In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,032 studies on the registry; 93 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse University of Sao Paulo studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy adults

Exclusion criteria

Exclusion Criteria:

  • Current or past history of cardiovascular disease, uncontrolled diabetes, liver disease, brain injury, head trauma with loss of consciousness, or other neurological and neurocognitive conditions;
  • any psychiatric diagnosis, assessed via the M.I.N.I. psychiatric interview (DSM-IV);
  • pregnant or breastfeeding women; prior experience (>2 lifetime uses) with ayahuasca;
  • current use of psychoactive medications (antidepressants, mood stabilizers, anxiolytics, stimulants, and antipsychotics);
  • marijuana use (more than 20 times in a lifetime); use of other drugs (psychostimulants: maximum of 20 lifetime uses; hallucinogens: maximum of 5 lifetime uses);
  • known allergy to the radiopharmaceutical used;
  • exposure to ionizing radiation within the past year; claustrophobia; or any other reason preventing the performance of the PET/CT scan.
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    ayahuasca

    ayahuasca

    Drug: Ayahuasca

Interventions

  • DrugAyahuasca

    ayahuasca 1.0 ml/kg

06

What researchers measure

Primary outcomes

  1. regional cerebral glucose metabolic rate (CMRglu) with [18F]-FDG PET

    Time frame: Baseline to 4 hours post-drug

07

Study locations

1 site
  • Universidade de São Paulo
    Ribeirão Preto, Brazil
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07893912
Lead sponsor
University of Sao Paulo
Responsible party
Rafael Guimarães dos Santos (Associate Professor, University of Sao Paulo) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 1, 2026
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Oct 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Sao Paulo →

Start the discussion