Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000155695p
Ethics application status
Not yet submitted
Date submitted
5/01/2023
Date registered
16/02/2023
Date last updated
16/02/2023
Date data sharing statement initially provided
16/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 308109 0
None
Universal Trial Number (UTN)
Trial acronym
AAMPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 327804 0
Condition category
Condition code
Neurological 324881 324881 0 0
Studies of the normal brain and nervous system
Mental Health 325633 325633 0 0
Studies of normal psychology, cognitive function and behaviour
Inflammatory and Immune System 325987 325987 0 0
Normal development and function of the immune system
Alternative and Complementary Medicine 325988 325988 0 0
Other alternative and complementary medicine
Neurological 325989 325989 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• 30 mg ayahuasca alkaloids; and
1.31 g l-epicatechin cyclodextrin complex
equivalent to 210 mg l-epicatechin; and
• Dissolved in water and propylene glycol in 50 mL bottles
• One single dose only, taken orally in the morning
Intervention code [1] 324556 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332690 0
Cholinesterase as assessed by blood pathology
Timepoint [1] 332690 0
Baseline and 1.5 hours post intervention
Primary outcome [2] 332693 0
Serotonin as assessed by blood pathology
Timepoint [2] 332693 0
Baseline and 1.5 hours post intervention
Primary outcome [3] 332694 0
Glutamate as assessed by blood pathology
Timepoint [3] 332694 0
Baseline and 1.5 hours post intervention
Secondary outcome [1] 414376 0
IL-6 as assessed by blood pathology
Timepoint [1] 414376 0
Baseline and 1.5 hours post intervention
Secondary outcome [2] 414377 0
TNF-a as assessed by blood pathology
Timepoint [2] 414377 0
Baseline and 1.5 hours post intervention
Secondary outcome [3] 417216 0
High-Sensitivity C-reactive protein (CRP) as assessed by blood pathology
Timepoint [3] 417216 0
Baseline and 1.5 hours post intervention
Secondary outcome [4] 417217 0
Erythrocyte sedimentation rate (ESR) assessed by blood pathology
Timepoint [4] 417217 0
Baseline and 1.5 hours post intervention
Secondary outcome [5] 417218 0
Cortisol as assessed by blood pathology
Timepoint [5] 417218 0
Baseline and 1.5 hours post intervention
Secondary outcome [6] 418213 0
Stress as measured by SAD PERSONS Scale
Timepoint [6] 418213 0
Baseline and 1.5 hours post intervention
Secondary outcome [7] 418214 0
Anxiety as measured by SAD PERSONS Scale
Timepoint [7] 418214 0
Baseline and 1.5 hours post intervention
Secondary outcome [8] 418215 0
Depression as measured by SAD PERSONS Scale
Timepoint [8] 418215 0
Baseline and 1.5 hours post intervention
Secondary outcome [9] 418216 0
Blood pressure (BP) as measured by telemetry
Timepoint [9] 418216 0
Baseline, 1.5 hours post intervention, and 4 hours post intervention
Secondary outcome [10] 418217 0
Heart rate (HR) as measured by telemetry
Timepoint [10] 418217 0
Baseline, 1.5 hours post intervention, and 4 hours post intervention
Secondary outcome [11] 418218 0
Oxygen saturation (SPO2) as measured by telemetry
Timepoint [11] 418218 0
Baseline, 1.5 hours post intervention, and 4 hours post intervention
Secondary outcome [12] 418219 0
Heart electrical signals as measured by electrocardiograam (ECG)
Timepoint [12] 418219 0
Baseline, 1.5 hours post intervention, and 4 hours post intervention

Eligibility
Key inclusion criteria
• Participant is willing and able to give informed consent for participation in the trial
• Adults aged 25-60 years inclusive
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/05/2023
Actual
Date of last participant enrolment
Anticipated
24/05/2023
Actual
Date of last data collection
Anticipated
1/06/2023
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312365 0
Commercial sector/Industry
Name [1] 312365 0
Biochem Industries Pty Ltd
Country [1] 312365 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Biochem Industries Pty Ltd
Address
Suite 1395, 17 Gould Road
Herston, QLD 4006, AU
Country
Australia
Secondary sponsor category [1] 314605 0
None
Name [1] 314605 0
Address [1] 314605 0
Country [1] 314605 0
Other collaborator category [1] 282518 0
Charities/Societies/Foundations
Name [1] 282518 0
Independant Food and Therapeutic Assessor Ltd
Address [1] 282518 0
Suite 1395, 17 Gould Road
Herston, QLD 4006, AU
Country [1] 282518 0
Australia
Other collaborator category [2] 282548 0
Commercial sector/Industry
Name [2] 282548 0
Thompson Health Services Pty Ltd
Address [2] 282548 0
Suite 1395, 17 Gould Road
Herston, QLD 4006, AU
Country [2] 282548 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311724 0
Human Research Ethics Committee, University of Canberra
Ethics committee address [1] 311724 0
11 Kirinari Street,
Bruce, ACT 2617, AU
Ethics committee country [1] 311724 0
Australia
Date submitted for ethics approval [1] 311724 0
18/04/2023
Approval date [1] 311724 0
Ethics approval number [1] 311724 0

Summary
Brief summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122142 0
Mr Victor Chiruta
Address 122142 0
Independent Food and Therapeutic Assessor Ltd
Suite 1395, 17 Gould Road
Herston, QLD 4006, AU
Country 122142 0
Australia
Phone 122142 0
+61 411 086 982
Fax 122142 0
Email 122142 0
victor@zkqgroup.com.au
Contact person for public queries
Name 122143 0
Mr Cameron Donley
Address 122143 0
Independent Food and Therapeutic Assessor Ltd
Suite 1395, 17 Gould Road
Herston, QLD 4006, AU
Country 122143 0
Australia
Phone 122143 0
+61 423 001 745
Fax 122143 0
Email 122143 0
cameron@zkqgroup.com.au
Contact person for scientific queries
Name 122144 0
Mr Robert Renshaw
Address 122144 0
Independent Food and Therapeutic Assessor Ltd
Suite 1395, 17 Gould Road
Herston, QLD 4006, AU
Country 122144 0
Australia
Phone 122144 0
+61 450 254 922
Fax 122144 0
Email 122144 0
rob@zkqgroup.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.