The Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults
NCT ID: NCT06967051
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
20 participants
INTERVENTIONAL
2025-05-22
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Can SOBEREYE OPTOVERA detect PLR alterations following cannabis consumption in healthy adults, in comparison to a pupillometer?
Participants will be given two 5 mg capsules to be ingested for the 10 mg THC dose or five 5 mg capsules to be ingested for the 25 mg THC. Participants will be asked to complete PLR tests throughout the study day.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
NCT04799093
Using Imaging to Assess Effects of THC on Brain Activity
NCT03655717
VRT as a Biomarker of Cerebellar Dysfunction in Chronic Cannabis Use
NCT03662737
The Neural Correlates of Cannabis Use
NCT03104257
UH3 Varenicline for Cannabis Use Disorder
NCT03980561
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tetrahydrocannabinol (10 mg)
10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule.
Tetrahydrocannabinol (10 mg)
10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule
Pupillary Light Reflex (PLR) Test
SOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR)
Pupillometer
NeuroLight is an automated pupillometer that generates a flash of light and measures the photomotor reflex very accurately.
Tetrahydrocannabinol (25 mg)
25 mg of THC provided as a softgel capsule.
Tetrahydrocannabinol (25 mg)
25 mg of THC provided as a softgel capsule.
Pupillary Light Reflex (PLR) Test
SOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR)
Pupillometer
NeuroLight is an automated pupillometer that generates a flash of light and measures the photomotor reflex very accurately.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tetrahydrocannabinol (10 mg)
10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule
Tetrahydrocannabinol (25 mg)
25 mg of THC provided as a softgel capsule.
Pupillary Light Reflex (PLR) Test
SOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR)
Pupillometer
NeuroLight is an automated pupillometer that generates a flash of light and measures the photomotor reflex very accurately.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
1. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
2. Double-barrier method
3. Intrauterine devices
4. Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
5. Vasectomy of partner at least 6 months prior to screening
6. Abstinence and agrees to use contraception if planning on becoming sexually active during the study
3. Self-reported cannabis users based on the Cannabis Use Questionnaire who are familiar and experienced with THC's acute psychoactive effects from the doses and route of administration to be used in this study without previous severe adverse reactions after cannabis ingestion
4. Self-reported cannabis use at least 3x per month but no more than 3x per week
5. Agrees to abstain from cannabis use for 3 days prior to study visit
6. Willingness to complete all assessments associated with the study and agrees to safe transportation home
7. Provided voluntary, written, informed consent to participate in the study
Exclusion Criteria
2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption study products
3. Current and ongoing neurological or ophthalmological issue that could affect the retina (blindness, glaucoma, dry eyes, retinal diseases, pupil abnormalities, cataracts, sensitivity to bright lights)
4. History of surgery on eyes or retinas except for laser corneal surgery
5. Current or history of psychological disorders (e.g., schizophrenia and psychosis)
6. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
7. Type I or Type II diabetes with diabetic retinopathy
8. Unstable metabolic disease or chronic diseases as assessed by the QI
9. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (see below)
10. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
11. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
12. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
13. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
14. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
15. Individuals with an unstable autoimmune disease
16. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
17. Alcohol or drug abuse within the last 12 months
18. Impairment from illicit drugs or alcohol during their study visit, as assessed by the QI or Sub-Investigator
19. Alcohol intake average of \>2 standard drinks per day as assessed by the QI
20. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (see below)
21. Participation in other research studies 30 days prior to baseline, as assessed by the QI
22. Individuals who are cognitively impaired and/or who are unable to give informed consent
23. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
21 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KGK Science Inc.
INDUSTRY
Sobereye Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Crowley, MD
Role: PRINCIPAL_INVESTIGATOR
KGK Science Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KGK Science Inc.
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24SICFP01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.