Healthy Women VolunteersNCT07317219
Ayahuasca, Esketamine and Body Image Perception
A study testing Ayahuasca and Esketamine in people with Healthy Women Volunteers, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on women body perception. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women Volunteers
- What is being tested?
- Ayahuasca and Esketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2025to Jul 2026
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- psychiatric and other medical comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da FMRP-USP
Ribeirão Preto, São Paulo, 14049900
Rafael Guimarães Santos, 5516997721969, banisteria@gmail.com
About this study
Official title: Effects of a Single Dose of Ayahuasca or Esketamine on Body Image Perception in Women: a Randomized, Double-blind Study
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on women body perception.
- Conditions
- Healthy Women Volunteers
- Being tested
- Ayahuasca, Esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyahuascaDrug
Also called aya
oral ayahuasca
EsketamineDrug
Also called ketamine
oral esketamine
| Study group | Role | What they receive |
|---|---|---|
| ayahuasca | Experimental | oral ayahuasca Receives: Drug: Ayahuasca |
| esketamine | Active comparator | oral esketamine Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Shape Questionnaire
higher scores mean a worse outcome
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start20 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Women VolunteersStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT07317219
- Sponsor's protocol ID
- 83923024.0.0000.5440
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Dose of Ayahuasca or Esketamine on Body Image Perception in Women: a Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT07317219
- Acronym / sponsor ID
- 83923024.0.0000.5440
- Conditions
- Healthy Women Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Jan 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.
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on women body perception.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ayahuasca | Experimental | Drug: Ayahuascaoral ayahuasca |
| esketamine | Active comparator | Drug: Esketamineoral esketamine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- psychiatric and other medical comorbidities
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 |
|---|---|---|
| AyahuascaAlso: ayaoral ayahuasca | Drug | ayahuasca |
| EsketamineAlso: ketamineoral esketamine | Drug | esketamine |
Primary outcome
Body Shape Questionnaire
Time frame: From enrollment to the end of treatment at 3 weeks
higher scores mean a worse outcome
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 5 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayahuasca and Esketamine in people with Healthy Women Volunteers, 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 1 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: looking for participants now, as of the sponsor's last update on 5 Jan 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Shape Questionnaire (time frame: From enrollment to the end of treatment at 3 weeks). 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 5 Jan 2026.