Clinical TrialAyahuascaEsketamineRecruiting

Ayahuasca, Esketamine and Body Image Perception

This randomised, double-blind, parallel trial (n=20) will study the effects of a single dose of oral ayahuasca or oral esketamine on body image perception in healthy female volunteers aged 18–65, with the primary outcome assessed using the Body Shape Questionnaire over a 3-week period. The study purpose is basic science investigation of acute effects on body perception. Participants will be randomised to one of two arms—oral ayahuasca (experimental) or oral esketamine (active comparator)—in a double-blind design; enrolment is limited to healthy women without psychiatric or other medical comorbidities. Body Shape Questionnaire scores will be collected from enrolment to the end of treatment at 3 weeks. The trial is sponsored by the University of Sao Paulo and is scheduled to run from December 2025 to July 2026.

Target Enrollment
20 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on women body perception.

Study Arms & Interventions

ayahuasca

experimental

oral ayahuasca

Interventions

  • Ayahuasca
    via Oralsingle dose1 doses total

esketamine

active comparator

oral esketamine

Interventions

  • Esketamine
    via Oralsingle dose1 doses total

Participants

Ages
1865
Sexes
female

Inclusion Criteria

  • healthy volunteers

Exclusion Criteria

  • psychiatric and other medical comorbidities

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2025-12-20
    End: 2026-07-01
  • Compounds

Study Team

Sponsors & Collaborators

Locations

Hospital das Clínicas da FMRP-USPRibeirão Preto, São Paulo, Brazil

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