Actively Recruiting
An Open Label Pilot Study Evaluating the Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use in Healthy Adults
Led by Sobereye Inc. · Updated on 2025-07-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sobereye Inc.
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new smartphone-based test called SOBEREYE OPTOVERA to measure changes in the Pupillary Light Reflex (PLR) after cannabis use in healthy adults. The study aims to compare the accuracy of this smartphone test to a standard pupillometer in detecting PLR changes following cannabis consumption. This open-label pilot study focuses on adults familiar with the effects of THC and investigates two different doses of the drug. Participants will receive either 10 mg or 25 mg of Tetrahydrocannabinol (THC) in softgel capsules to ingest during the study. The 10 mg dose involves two 5 mg capsules, while the 25 mg dose involves five 5 mg capsules. During the study day, participants will complete PLR tests using both the smartphone test and the NeuroLight pupillometer at multiple time points to assess the reflex changes due to cannabis. Throughout the study, participants will undergo repeated PLR assessments at intervals ranging from 0 to 480 minutes after dosing to capture detailed reflex responses over time. Reaction time and subjective drug effects will also be measured as secondary outcomes. The study requires participants to abstain from cannabis for 3 days prior and involves safe transportation home after the visit. The total participation timeline is within a single study day, with ongoing monitoring of pupillary responses and reaction times.
CONDITIONS
Brief Title
The Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 21 years of age or older
- Females not able to become pregnant or using medically approved birth control methods during the study
- Self-reported cannabis users familiar with THC effects and without previous severe adverse reactions
- Cannabis use at least 3 times per month but no more than 3 times per week
- Willing to abstain from cannabis for 3 days before study visit
- Willing to complete all study assessments and agree to safe transportation home
- Provided voluntary, written informed consent to participate
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy, sensitivity, intolerance, or dietary restrictions preventing consumption of study products
- Current or ongoing neurological or eye problems affecting the retina or pupils
- History of eye or retina surgery except laser corneal surgery
- Current or past psychological disorders such as schizophrenia or psychosis
- Significant gastrointestinal diseases
- Diabetes with diabetic retinopathy
- Unstable metabolic or chronic diseases
- Unstable hypertension or recent significant cardiovascular events
- Kidney or liver diseases except symptom-free kidney stones
- Thyroid conditions unless stable on medication
- Major surgery in past 3 months or planned surgery during study
- Cancer except fully excised skin basal cell carcinoma or cancer in remission over 5 years
- Unstable autoimmune disease
- HIV, Hepatitis B or C infection
- Alcohol or drug abuse in past 12 months
- Impairment from illicit drugs or alcohol during study visit
- Average alcohol intake more than 2 standard drinks per day
- Use of medications or supplements that may affect study product safety or efficacy
- Participation in other research within 30 days prior to baseline
- Cognitive impairment or inability to give informed consent
- Any other condition or lifestyle factor that may affect study completion or safety according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 8 hours on the study visit day
Participants receive a single dose of Tetrahydrocannabinol (THC) and undergo Pupillary Light Reflex tests using a smartphone-based test and an automated pupillometer to measure changes following cannabis use.
1 in-person visit lasting several hours with multiple assessments during the visit
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada
Actively Recruiting
Research Team
E
Erin Lewis, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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