Methodology
This study was conducted with 78 test subjects. Twenty participants inhaled 9-12 puffs of the Pure Sunfarm Pink Kush pre-roll that contains 170.00 – 230.00 mg/g of THC, 28 test subjects consumed the gummy Wana Quick – Pineapple Coconut containing 10 mg of THC and 29 test subjects consumed the beverage XMG – Mango Pineapple containing 10 mg of THC.
Zentrela’s non-invasive portable EEG device and desktop application were used to record consumer EEG data from 8 different regions of the brain (right and left sides of the frontal, temporal, parietal and occipital lobes). The standardized process of collecting EEG data (called ‘EEG Test’’) consists of approx. two-minute-long recordings depending on the quality and integrity of the EEG data that is being recorded. Internal and external noise is ignored. Two EEG Tests were administered before product consumption to calibrate the Cognalyzer® AI solution and seven more EEG tests were administered after 5, 10, 15, 20, 25, 30, 45, 60 and 120 minute product consumption.
Cognalyzer EEG (brainwave) analysis was used to convert EEG Tests into THC psychoactive effect levels (PEL) in a standardized scale from 0% to 100%. (Learn more about it in the following section). The cubic spline interpolation method was used to accurately characterize PELs minuteby minute-post product-consumption and per participant/visit. Then the PELs of all the beverage consumers were aggregated.
Statistical analysis was conducted to determine the higher and lower bounds of the aggregated PELs using >90% confidence intervals. The onset time interval of the beverage psychoactive effect curve was determined by getting the time point of the first aggregated PEL above 5% and the time point of the first aggregated PEL above 15% when their lower bound of the confidence interval is above 90%.
The maximum potency and the time of this peak per product was determined by finding the maximum PEL of each curve and its time point.
Study results
11-20 minutes after consumption. Finally, for the Wana Quick Pineapple Coconut edible, the onset time interval was 24-38 minutes post consumption.
With regard to the potency of each product, the maximum potency created by the Pure Sunfarms Pink Kush pre-roll was 60.3%. This maximum PEL was reached approximately 20 minutes post consumption. In the case of the XMG – Mango Pineapple beverage, the maximum PEL was 38.50%, and it was experienced approximately 60 minutes post consumption. Finally, the maximum potency of the Wana Quick Pineapple Coconut edible was 37.85 % and it was achieved ~90 minutes post consumption.
Although the pre-roll showed the maximum potency, the exact amount of THC that was absorbed by each participant cannot be quantified through any known method. An interesting finding of this study, is that both, the beverage and the edible, have similar THC potencies. This was expected given the fact that the two products contained 10 mg of THC.
Cognalyzer® EEG (brainwave) analysis
After five years (2016-2021) of full R&D laser-focused efforts the neurotechnology company Zentrela, Inc. which is led by Israel Gasperin, an engineer,entrepreneur, and founder of Zentrela; and Dr. Dan Bosnyak, a McMaster neuroscientist, Director of the neuroscience McMaster LIVELab, and CSO of Zentrela, developed the only scientifically proven method, (called Cognalyzer®) for objectively quantifying the actual effects cannabis products have on the brain. Its novelty and unprecedented accuracy relies on using Machine Learning in large EEG datasets to do complex EEG analysis that we humans have not been able to do in order to find complex but specific EEG features directly associated with the effects substances like THC have on the brain.
The second novelty of Zentrela’s solution is a standardized method for recording EEG data (called ‘EEG Test’) and quantifying the presence of a substance effect. The drug effect quantification method consists of recording approximately 2 mins of EEG data from eight different regions of the brain (right and left sides of the frontal, temporal, parietal and occipital lobes) using Zentrela’s proprietary EEG headset calculating and then calculating the amount of time (within the approximately 2-min recording) that a subject is experiencing EEG alterations. The amount of time is calculated by the number of EEG segments that are classified by Zentrela’s scientifically validated AI as “altered” by the THC effect (called “PEL”).
- The accuracy and objectivity of the Cognalyzer measurement of cannabis psychoactive effects has been independently validated by the clinical research organization, KGK Science, Inc., and the following peer-reviewed publications:
https://link.springer.com/article/10.1007/s12325-021-01718-6
https://link.springer.com/article/10.1007/s40120-021-00293-w
- Since 2021, Zentrela has been using its proprietary neurotechnology, among other research tools, to independently quantify the non-therapeutic cannabis effects of cannabis products (beverages, edibles, and inhalables) and other key contributing factors like consumer information (demographics, psychographics, etc.) and product consumption patterns (consumption amount, method, duration, etc.).
- After having conducted Observational studies since 2021 with many hundreds of consumers on tens of legal products, Zentrela has amassed the world’s largest scientifically derived database of cannabis effects. The purpose of developing this new type of scientific evidence about cannabis effects is to share this information with all the stakeholders of the cannabis industry to help them accomplish their objectives in a faster, better, safer, and/or best possible way:
- Consumers, to have access to trustworthy, objective data backed by neuroscience in order to make informed purchase and consumption decisions.
- Brand owners, to conduct regulatory-compliant educational marketing at retail that generates product trial and differentiates their brand.
- Retailers, to differentiate their retail brand as a science-driven education business that helps them meet their mandate of supporting consumers to make informed decisions while moving products faster.
- Drug delivery companies, to objectively prove the efficacy (fast, strong, consistent effects) of their novel solution(s).
- Product developers, to reliably find optimal formulations that effectively create intended effects. They can use our neurotech internally in their labs or partner with us to externally conduct their research.
- E-commerce platforms, to enrich their platform with science-backed product effect content that will help consumers choose the right product for them.
Research Framework
Research Organization and Sponsor | Zentrela Inc. |
Scientific Research Model: | CUSIC™ non-therapeutic cannabis effect research |
Health Canada’s Research Framework: | Observational Study approved by an independent ethics research board (IRB) |
Independent Ethics Research Board (IRB): | Advarra Inc. |
Consumer Attestation: | Full informed consent form reviewed and approved by the IRB. |
Principal Investigator: | Dr. Dan Bosnyak |
Authors: | Dr. Dan Bosnyak, Upmanyu Sharma, Israel Gasperin Haaz |
GTIN# of cannabis products: | 00628188001550 – Pink Kush Pre-rolls created by Pure Sunfarms
00838860000133 – XMG – Mango and Pineapple beverage created by TRUSS. 0800447000768 – Wana Quick – Pineapple Coconut |
Cannabis Administration: | The participants in our study brought their own cannabis products and freely consumed them under our observation. Additionally, Zentrela validated that the participants obtained the products from the legally regulated Canadian market. |
Study Group Size: | 78 test subjects |
Research Tools: | Cognalyzer AI-driven EEG research tool |
Zentrela’s Research Facility Location: | CL1 231 Main St W, Hamilton, ON, L8P 1J4, CANADA. |
Collaborations
Contact us to explore research collaborations to leverage this objective science-backed data for additional
research, informational, educational, marketing, or regulatory purposes.
Roy Agostino – ragostino@zentrela.com