Welcome to the Sobereye Pupil Dilation Study. To move forward in this study you are required to watch the ICF (Informed Consent form) video and read through the ICF attached before attending your first screening visit. If you have any questions in regards to this ICF that is not answered in the FAQ section below or you would like further explanation, please come with your questions ready to your assigned appointment or email the clinic staff at clinic@kgkscience.com.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to the SOBEREYE Study.
In this video, the purpose of this study, the study design, risks and benefits and what is expected from the parent/guardian and the child if you decide to participate. After listening to this recording, please read the informed consent and assent forms as well as the Frequently Asked Questions. This video is meant for parents, legal guardians and the child to watch together. Some of the words we use in this video are directed more toward the parents/guardians, but that doesn’t mean the information is also not important to the child.
Sobereye introduction Video
2. ICF & Assent Consent Forms
Please take your time to read through both the ICF form, as you will be required to sign them at your initial screening visit should you qualify for the study.
Please do not sign them in advance as they must be signed at the visit after the study staff are assured all your questions have been answered.
ICF form - Please Review Here
3. Frequently Asked Questions
What is the Purpose of this Clinical Trial?
- Although legalization of recreational cannabis is increasing in North America, there is concern for workplace safety with increasing cannabis use among employees. Despite the widespread safety concerns of workplace cannabis use, tools to assess impairment are lacking.
- The pupillary light reflex (PLR) involves exposing the eye to light and then assessing how the pupil reacts. There are special tools to measure PLR but are costly, which limits accessibility and widespread use.
- The purpose of this study is to investigate the efficacy of Soberye Optovera, a smart phone-based test, in detecting PLR changes following cannabis use in health adults.
What is the study device? How does it work?
SOBEREYE OPTOVERA, the study device, is a protable, non-invasive hand-held device that measures pupillary light reflex (PLR). This smart phone-based test will be sued to detect PLF changes following cannabis use in healthy adults. Thea participant will place the device and mask over their closed eyes for 1-minute and the device will count down during this process. After the 1-minute countdown, the participant will open their eyes and the device will shine a light for 4 seconds. During this time, they will be instructed to keep their eyes open and avoid blinking.
Additional Devices used in the study include:
Neurolight is a portable, non-invasive hand-held device that measures the PLR. Study staff will place the device eyecup over the participant’s left eye. The participant will then cover their right eye with their hand. The device will shine a light for 4 seconds into the left eye and during this time, the participant will be instructed to keep their eye open and avoid blinking.
Dynavision board is a large, computerized board that lights up in a random order and will be used to measure participants’ reaction times. The participant will stand approximately 1 foot away from the board at eye level. A series of lights will turn on and whenever the participant sees a light, they are to press the buttons as quickly as they can.
These tests will be performed before and after cannabis consumption at specific time points.
Are there any side effects or risks with the device (s)?
The SOBEREYE OPTOVERA device may not accurately measure pupillary light reflex (PLR). The participant may experience discomfort due to the light from this test and the mask may also cause minor discomfort.
The Neurolight Pupillometer device may not accurately measure the PLR. The participant may experience discomfort due to the light from this test.
The Dynavision device may not accurately measure the reaction time. Repetitive reaching, pressing, and rapid movements may lead to strain, loss of balance, fall and/or overexertion.
Are there any side effects or risks with the Cannabis consumptions?
Cannabis contains substances that affect the brain and body, including delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC cause the intoxicating effects of cannabis. CBD is not intoxicating but can still have effects on the brain.
Cannabis use some short-term effects as well as long-term effects. When cannabis is used, it can:
Impair your ability to drive safely or operate equipment.
- Cannabis can cause drowsiness, slow reaction times, lower your ability to pay attention and impair coordination. Using cannabis and then driving or operating equipment can result in an accident, serious injuries or death.
Make it harder to learn and remember things.
- Cannabis can impair your thinking, concentration, memory and decision-making and can impact your ability to perform well on the job or at school.
Affect your mental health
- Though cannabis can cause euphoria (a high), it can also cause anxiety or panic
- In rare cases, cannabis can trigger a psychotic episode (not knowing what is real, experiencing paranoia, having disorganized thoughts and, in some cases, hallucinating)
Using cannabis frequently (daily or almost daily) and over a long time (several months or years) can:
- Hurt your lungs and make it harder to breathe, if smoked
- Cannabis smoke contains many of the same harmful chemicals found in tobacco smoke
- Affect your mental health
Frequent use of THC over a long time increase the risk of cannabis dependence, also called:
- Addiction
- Cannabis Use Disorder
- Problematic Cannabis Use
It is also associated with an increased risk of developing or worsening disorders related to anxiety and depression.
Using products with higher levels of THC (20% THC [200mg/g] or more) such as resin, hash oil, wax and distillates, further increases the risk of mental health problems over time.
Stopping or reducing your cannabis use can improve your mental health.
Potential side effects after using cannabis may also include fever, nausea, vomiting, loss of appetite, and abdominal discomfort.
How often and when do I need to complete the study examinations??
Before Cannabis Product Consumption:
50,40,30,20, and 10 minutes before:
- SOBEREYE Smart Phone-Based Test- You will place a device and mask over your eyes and follow instructions given by the study staff. Each measurement will take about 90 seconds to complete.
- Neurolight Pupillometer-Study staff will use this hand-held device to measure how your pupils will react and change in size. Each measurement will take about 15 seconds to complete.
Modified Drug Effects Questionnaire (DEQ-5) This questionnaire will be used to assess your personal experience with drug effects.
Dynavision Test is a large, computerized light board that lights up in a random order and will be used to measure your reaction time.
After Cannabis Product Consumptions:
- 5, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes after: Soberye smart phone based test, Neurolight pupillometer and modified DEQ-5
- 60, 120, 180, 240, 300, 360, 420 minutes after: Dynavision Test
- About 120-180 minutes after, you will be provided with a standardized lunch and snacks as needed
- Seated resting blood pressure and heart rate measurements
- Any changes in health will be assessed and recorded throughout the study visit
- You will remain in clinic until cleared to leave with a designated driver or transportation service
What other study assessment will be performed during this study?
Some study assessments that can be expected during the study include:
- SOBEREYE Smart Phone-Based Test
- NeuroLight Pupillometer
- Dynavision Test
- Cannabis Use Questionnaire, which will assess cannabis use habits
- Modified Drug Effects Questionnaire (DEQ-5), to assess personal experience with drug effects
- Individuals of child-bearing potential will be required to provide a urine sample for a urine pregnancy test
- Blood pressure and heart rate measurements
- Weight and height measurements. Body Mass Index (BMI) will be calculated.
What is the cannabis type, form, amount, ingredients, and mode of consumption?
- Cannabis type = Sativa (Cannabis Sativa plant)
- Cannabis form = Cannabis oil softgel capsule
- Quantity of the cannabinoid(s) – THC 5 mg/capsule; CBD 0-0.34 mg/capsule
- Ingredients = MCT oil, cannabis, terpenes (Alpha-Pinene, Beta-Myrcene, Beta-Ocimene, Beta-Pinene, Linalool)
- Eligible participants will be randomized (assigned to a study group by chance, like flipping a coin), to either 10mg or 25mg of THC.
- If randomized to 10mg of THC group, two 5mg softgel capsules will be consumed and if randomized to 25mg of THC group, five 5mg softgel capsules will be consumed.
- This is an open-label study. This means that the participant, the study staff and the Sponsor will know which group the participant is randomized to. However, neither the participant, the study staff or Sponsor can choose which group they are randomized to, ensuring the integrity of the trial.
The cannabis products used in this study are purchased over the counter and are available in stores.
THC – Tetrahydrocannabinol; CBD – Cannabidiol; MCT – Medium chain triglycerides; mg – milligrams
When do I find out how much cannabis I consumed?
- Eligible participants will be randomized (assigned to a study group by chance, like flipping a coin), to either 10mg or 25mg of THC (Tetrahydrocannabinol)
- If randomized to 10mg of THC group, two 5mg softgel capsules will be consumed and if randomized to 25mg of THC group, five 5mg softgel capsules will be consumed
- This is an open-label study. This means that the participant, the study staff, and the Sponsor will know which group the participant is randomized to. However, neither the participant, the study staff or Sponsor can choose which group they are randomized to, ensuring the integrity of the trial.
- Therefore, if you are eligible and randomized, you will know how much cannabis (10mg or 25mg) you are required to consume prior to cannabis consumption.
How long is the study? Do I have to come into the clinic for any assessments?
If eligible, participation in this study will consist of one in-clinic visit (Visit 1) lasting approximately 9 hours.
What does randomization mean?
You will be assigned by chance (like flipping a coin) to a study group. If eligible, you will be randomized to 1 of 2 groups:
- 10mg of THC (Cannabis oil softgel)
- 25mg of THC (Cannabis oil softgel)
This is an open-label study. This means that you, the study staff and the Sponsor will know which group you are randomized to. However, neither you, the study staff or Sponsor can choose which group you are randomized to, ensuring the integrity of the trial.
The cannabis products used in this study are purchased over the counter and are available in stores.
How will I get home after?
- You will need to arrange a designated person to provide transportation for you after the study visit. If this is not possible, the study staff can arrange transportation for you.
- Study staff will assess you at the end of the visit to ensure it is safe for you to leave. You will remain at the study clinic until your transportation has arrived and are cleared by study staff to leave.
Will I have to Abstain/Avoid cannabis consumption prior to participating in this study?
Yes, eligible participants will be required to avoid all forms of cannabis products for 3 days prior to the study visit.
Who do I contact if I have any questions?
If you have any questions, you can contact our study staff at the following email address: clinic@kgkscience.com
What is the compensation for participating?
For your time and participation in the study, you will be compensated a total of 150$ if you complete the entire study and all associated requirements. If, for any reason, you are unable to complete ALL study assessments, you will not be eligible for compensation.
How and when will I receive my compensation for participating?
- After completion of the study, you will receive your compensation on a ClinCard.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
Is my participation confidential?
Yes! KGK Science research staff will keep all of your personal medical information confidential to the extent required by law. You will not be identified in any publication that may result from the study.
Do I have to consume the entire dose of the cannabis provided during the study?
Yes! As part of the study, participants must consume the entire dose of cannabis, otherwise they are excluded from the study. If only able to consume a partial dose, participant must stay in clinic until a clinic staff declares it is safe for you to leave. If you do not consume the required amount of cannabis, you would not be eligible for study compensation.
Do I need to bring anything with me to the clinic visit?
You will need to present in clinic with a valid piece of photo ID, everything else is optional. You will be in clinic for a total of 9 hours, you are welcome to bring a book or something for entertainment. You will be asked to put it aside for the timed study procedures though.
A Standardized meal will be provided to you at no cost to yourself, and snacks will be provided.
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For More information on this Study Please contact the clinic Staff at:
clinic@kgkscience.com
