ACTRN12623000155695
Not Yet Recruiting
Phase 1
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
Biochem Industries Pty Ltd0 sites5 target enrollmentFebruary 16, 2023
ConditionsCognitive impairmentNeurological - Studies of the normal brain and nervous systemMental Health - Studies of normal psychology, cognitive function and behaviourInflammatory and Immune System - Normal development and function of the immune systemAlternative and Complementary Medicine - Other alternative and complementary medicine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cognitive impairment
- Sponsor
- Biochem Industries Pty Ltd
- Enrollment
- 5
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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