Clinical TrialHealthy VolunteersAyahuascaNot yet recruiting

A pilot study testing the feasibility of a single microdose of ayahuasca alkaloids on neurotransmitters, inflammation marker levels, safety, and mood in healthy adult volunteers

This interventional pilot study (n=4; target n=5) tests a single oral microdose (30 mg ayahuasca alkaloids co-formulated with l‑epicatechin complex) in healthy adults aged 25–60 to assess blood neurotransmitters, IL-6, safety, and mood.

Target Enrollment
5 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

Single-group, open-label, non-randomised pilot in healthy volunteers assessing a single morning oral microdose of ayahuasca alkaloids (30 mg) co-administered with an l‑epicatechin cyclodextrin complex; biological samples collected at baseline and 1.5 hours post-dose.

Primary measures include blood cholinesterase and IL-6 at baseline and 1.5 hours post-intervention, along with safety observations and mood/self-efficacy assessments.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ayahuasca microdose

experimental

Single oral microdose of ayahuasca alkaloids co-formulated with l‑epicatechin cyclodextrin complex.

Interventions

  • Ayahuasca30 mg
    via Oral• single dose

    Dissolved in water and propylene glycol in 50 mL bottle; taken in the morning.

  • Compound210 mg
    via Oral• single dose

    l‑epicatechin equivalent from 1.31 g cyclodextrin complex (210 mg l‑epicatechin).

Participants

Ages
25 – 60
Sexes
Male & Female

Inclusion Criteria

  • Participant is willing and able to give informed consent for participation in the trial
  • Adults aged 25–60 years inclusive
  • Healthy adult volunteers

Exclusion Criteria

  • Current use of any prescribed psychotropic medication
  • Significant renal or hepatic impairment as judged by study clinicians
  • Cardiovascular conditions including abnormal heart rate or blood pressure; threshold for exclusion: systolic >160 mmHg or diastolic >90 mmHg averaged across four assessments on screening day
  • Any unstable medical or neurologic condition
  • Current or past history diagnosis of schizophrenia or other psychotic disorders, or Bipolar I or II Disorder
  • Imminent risk of suicide
  • Lifetime presence of diagnosis of Major Depressive Disorder not in remission
  • Current diagnosis of panic disorder, OCD, dysthymic disorder, anorexia, or bulimia
  • Body weight <50 kg or >120 kg
  • Substance dependence diagnosis in the previous three months

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment5 participants
  • Timeline
    Start: 2023-05-14
    End: 2023-06-01
  • Compound
    Ayahuasca
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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