Clinical TrialAyahuascaNot yet recruiting

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

Target Enrollment
5 participants
Study Type
Phase interventional
Design
Randomized

Detailed Description

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.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ayahuasca

Participants

Inclusion Criteria

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

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 to be checked at screening. A threshold of exceeding 160 mmHg (systolic) and 90 mmHg (diastolic), averaged across four assessments taken on the screening day will be used
  • 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 disorders, 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
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment5 participants
  • Timeline
    Start: 2023-05-14
    End: 2023-05-24
  • Compound
    Ayahuasca

Locations

Unknown facility — Australia

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