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

Phase 1

• Conditions: Cognitive impairment; Neurological - Studies of the normal brain and nervous system; Mental Health - Studies of normal psychology, cognitive function and behaviour; Inflammatory and Immune System - Normal development and function of the immune system; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12623000155695
• Lead Sponsor: Biochem Industries Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cholinesterase as assessed by blood pathology[Baseline and 1.5 hours post intervention];Serotonin as assessed by blood pathology[Baseline and 1.5 hours post intervention];Glutamate as assessed by blood pathology[Baseline and 1.5 hours post intervention]