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
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
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
[email protected]
Contact person for public queries
Name 122143 0
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
[email protected]
Contact person for scientific queries
Name 122144 0
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
[email protected]

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.