A pilot study to test the effects of a single microdose of ayahuasca alkaloids on blood pathology of neurotransmitters and inflammation marker levels, safety observations, and mood self-efficacy in healthy adults

This open-label pilot study (n=5) aims to assess the feasibility of a single microdose of ayahuasca alkaloids (30mg) on neurotransmitter and inflammation marker levels, safety observations, and mood self-efficacy in healthy adults.

Conducted by Biochem Industries Pty Ltd in Australia, the study involves administering a single dose of 30 mg ayahuasca alkaloids and 1.31 g l-epicatechin cyclodextrin complex dissolved in water and propylene glycol.

Participants, aged 25-60, will be closely monitored for safety measures, including blood pressure, heart rate, and oxygen saturation. The study hypothesis is that the microdose will affect neurotransmitter levels and mood positively. Mr. Victor Chiruta from Independent Food and Therapeutic Assessor Ltd is the principal investigator. The study aims to recruit four participants and is expected to be conducted from May to June 2023. No individual participant data will be shared.

Topic Healthy Subjects Microdosing
Compound Ayahuasca
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 14 May 2023
End date 01 June 2023
Chance of happening 80%
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.

NCT Number ACTRN12623000155695p

Data attribution

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