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.
Trial Details
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