This open-label Phase trial (n=5) evaluated the safety and efficacy of ayahuasca for cognitive impairment.
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.