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) is designed to explore the effects of a single microdose of ayahuasca alkaloids on blood pathology of neurotransmitters and inflammation markers, safety observations, and mood self-efficacy in healthy adults.

The trial acronym is AAMPS, and it is conducted by Biochem Industries Pty Ltd, with additional collaboration from Independant Food and Therapeutic Assessor Ltd and Thompson Health Services Pty Ltd.

The primary intervention involves a single oral dose of 30 mg ayahuasca alkaloids and 1.31 g l-epicatechin cyclodextrin complex dissolved in water and propylene glycol. The study aims to assess the impact on various blood pathology markers, including cholinesterase, serotonin, glutamate, IL-6, TNF-a, high-sensitivity C-reactive protein, erythrocyte sedimentation rate, cortisol, and others. Safety observations will include blood pressure, heart rate, oxygen saturation, and heart electrical signals.

The eligibility criteria include adults aged 25-60 who are willing to provide informed consent. The recruitment status is not yet recruiting, with an anticipated start date in May 2023.

The study is funded by Biochem Industries Pty Ltd, and ethics approval is pending from the Human Research Ethics Committee, University of Canberra, Australia. The principal investigator is Mr Victor Chiruta, and contacts for public and scientific queries are Mr Cameron Donley and Mr Robert Renshaw, respectively. The trial website and data sharing statement indicate no additional documents or individual participant data will be available.

Topic Neuroscience Healthy Subjects
Compound Ayahuasca
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 14 May 2023
End date 01 June 2023
Phase Not Applicable
Design Open
Type Interventional
Generation First
Participants 5
Sex All
Age 25- 60
Therapy No

Trial Details

This clinical study is an uncontrolled, non-randomised, open-mask, pilot study aiming to test the feasibility of a single microdose of ayahuasca alkaloids on neurotransmitters and inflammation blood pathology markers. This pilot study will recruit four healthy adult volunteers with strict exclusion criteria. This study will test whether an ayahuasca microdose has any measurable biological effects outside of the subjective mood self-efficacy effects. This study will also measure safety observations such as blood pressure, heart rate, pain and oxygen saturation (SPO2). The study hypotheses is that a single microdose of ayahuasca alkaloids will increase neurotransmitters, decrease or have no effect on inflammation markers, have no effect on safety observations, and may enhance mood.

Trial Number ACTRN12623000155695p

Data attribution

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