Healthy Adult ParticipantsEarly Phase 1NCT07893912
Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study
A Early Phase 1 study testing Ayahuasca in people with Healthy Adult Participants, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Open-label trial with healthy adults Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Ayahuasca
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
- Conditions
- Healthy Adult Participants
- Being tested
- Ayahuasca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyahuascaDrug
ayahuasca 1.0 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| ayahuasca | Experimental | ayahuasca Receives: Drug: Ayahuasca |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional cerebral glucose metabolic rate (CMRglu) with [18F]-FDG PET
Measured: Baseline to 4 hours post-drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Guimarães dos Santos, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893912
- Sponsor's protocol ID
- 83248624.9.0000.5440
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study
- ClinicalTrials.gov ID
- NCT07893912
- Acronym / sponsor ID
- 83248624.9.0000.5440
- Conditions
- Healthy Adult Participants
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label trial with healthy adults
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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ayahuasca | Experimental | Drug: Ayahuascaayahuasca |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ayahuascaayahuasca 1.0 ml/kg | Drug | ayahuasca |
Primary outcome
regional cerebral glucose metabolic rate (CMRglu) with [18F]-FDG PET
Time frame: Baseline to 4 hours post-drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ayahuasca in people with Healthy Adult Participants, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regional cerebral glucose metabolic rate (CMRglu) with [18F]-FDG PET (time frame: Baseline to 4 hours post-drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.