Introduction
In recent years, the cannabis industry has expanded its product offerings beyond traditional consumption methods, such as smoking or edibles. The introduction of cannabinoids in beverages represents a significant and promising advancement in this area. This unique delivery method provides distinct advantages for consumers and broadens the scope of usage. Cannabis-infused beverages have been heralded for their fast acting effects and versatility, making them a great alternative for social gatherings and indoor events. Furthermore, drinking is discrete and socially acceptable, broadening their appeal to a wider range of consumers.
A significant focus in this burgeoning sector of the cannabis industry has been the development of advanced drug delivery systems that use emulsification to stabilize cannabinoids in aqueous solutions. However, cannabis-infused beverage companies have faced challenges to objectively and accurately demonstrate the fast acting efficacy of their products. Existing evidence about the efficacy of drug delivery methods has been carried on through pharmacokinetic studies that quantify concentration levels of a substance, like THC, in body fluids, such as blood, urine, and saliva.
However, there is no direct correlation between THC concentration levels in the body and the actual effects this cannabinoid creates on the brain when it is acting. After the THC effect disappears (offset time), this substance remains in body fluids several hours or days, which makes it hard to accurately determine the actual onset time of the THC psychoactive effect.
Zentrela has introduced a novel and standardized method for objectively quantifying the effects cannabis has on the brain, called Cognalyzer®, that is based on electrical brain activity (EEG data) analysis. Our non-invasive EEG neurotechnology records the EEG of cannabis consumers from multiple regions of the brain (right and left sides of the frontal, temporal, occipital and parietal brain lobes) in a standardized, safe and easy way. EEG analysis is conducted through scientifically validated Machine Learning algorithms that detect complex but specific brain activity changes in different regions of the brain specifically triggered by THC. Read more about it in the section: Cognalyzer® EEG (brainwave) analysis.
In this publication, we present the results of using the Cognalyzer® EEG-based method to analyze the brain activity of 174 test subjects who consumed 3 beverages (Deep Space, XMG – Mango and Pineapple, and Versus Black Cherry Rapid Seltzer) manufactured by different companies.
Our results provide the first EEG-based objective and quantitative evidence about the fast acting efficacy of beverages emulsified with 10 mg of THC to create psychoactive effects.
Methodology
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 ~2-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 7 more EEG tests were administered after 5, 10, 15, 20, 25, 30, 45, and 60 mins 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%. The cubic spline interpolation method was used to accurately characterize PELs minute by 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 the lower bound of the confidence interval is above 90%.
Study Results
The results of this EEG-based study with 89 test subjects characterizes the rapidness of cannabis beverages, with 10 mg of THC, to create psychoactive effects. Ninety percent (90%) of the beverage consumers, who participated in this study, started to experience the THC psychoactive effect of 10 mg THC beverages between 11 and 20 minutes (Beverage onset time) post consumption. The Figure displayed above shows the characterized THC psychoactive effect profile of beverages. The statistical analysis, definition and characterization of the onset time information is explained in the Methodology section.
Subsequent scientific articles will be published to study the specific onset time of each beverage (per SKU) given the fact that each one is formulated differently to create unique cannabis experiences. It’s important to highlight that beverages with a lower or higher amount of THC (e.g. 2 mg or 100 mg) may significantly alter the onset time of a cannabis product. Further articles will provide objective evidence about this.
In addition, we’re in the process of studying and publishing more scientific articles about the psychoactive effects of edibles and inhalables like pre-rolls and vapes.
If you’re interested in using our portable neurotechnology for your own research or licensing these study results for educational, informational, promotional, e-commerce, or research purposes, please contact Roy Agostino at ragostino@zentrela.com.
Cognalyzer® EEG (brainwave) Analysis
After 5 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 had 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 ~2 mins of EEG data from 8 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 ~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: | 00688083002779 – Deep Space from Canopy Growth.
00838860000133 – XMG – Mango and Pineapple beverage from Truss Beverages. 00824164000993 – Versus Black Cherry Rapid Seltzer beverage from Valens |
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: | 174 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. |
Conclusion
Using our scientifically validated Machine Learning algorithms, non-invasive neurotechnology and novel EEG-based method for measuring cannabis’ psychoactive effects, we determined the average onset time interval of 3 beverages that contain 10 mg of THC but are developed by different licensed producers.
These results demonstrate one of the several ways our EEG-based research can be used to study the effects of cannabis in a more objective, accurate, quantitative way. In addition to the onset time determination, our first AI solution, called GA56, can characterize the THC effect potency, duration, and other effects. These findings just described will be released soon.
It’s important to highlight that these findings only represent an average onset time of three beverages. The actual onset time of each beverage will be published in subsequent studies.
Through this comprehensive investigation, we aim to contribute valuable insights into the onset time of the THC psychoactive effect associated with the beverage consumption method, thereby enhancing informed decision-making for cannabis consumers.
Collaborations
Contact us to explore research collaborations to leverage this objective science-backed data for additional research, informational, educational, marketing, e-commerce or regulatory purposes.
Roy Agostino – ragostino@zentrela.com