Cannabis IntoxicationNCT06967051
The Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults
A study testing Tetrahydrocannabinol (10 mg), Tetrahydrocannabinol (25 mg) and Pupillary Light Reflex (PLR) Test in people with Cannabis Intoxication and Drug Effects, run by Sobereye Inc. at 1 site in Canada.
Trial summary
The goal of this open label study is to evaluate the efficacy of smart phone-based test (SOBEREYE OPTOVERA) on measuring pupillary light reflex (PLR) alterations following cannabis use healthy in adults. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Intoxication, Drug Effects
- What is being tested?
- Tetrahydrocannabinol (10 mg), Tetrahydrocannabinol (25 mg) and Pupillary Light Reflex (PLR) Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2025to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 21 years of age or older
- 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:
- 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)
- Double-barrier method
- Intrauterine devices
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- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- 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
- Self-reported cannabis use at least 3x per month but no more than 3x per week
- Agrees to abstain from cannabis use for 3 days prior to study visit
- Willingness to complete all assessments associated with the study and agrees to safe transportation home
- Provided voluntary, written, informed consent to participate in the study
Who cannot join
- Individuals who are pregnant, breast feeding or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption study products
- 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)
- History of surgery on eyes or retinas except for laser corneal surgery
- Current or history of psychological disorders (e.g., schizophrenia and psychosis)
- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
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- Type I or Type II diabetes with diabetic retinopathy
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (see below)
- 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
- 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
- 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
- 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
- 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
- Individuals with an unstable autoimmune disease
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Impairment from illicit drugs or alcohol during their study visit, as assessed by the QI or Sub-Investigator
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- 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)
- Participation in other research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Pilot Study Evaluating the Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults
The goal of this open label study is to evaluate the efficacy of smart phone-based test (SOBEREYE OPTOVERA) on measuring pupillary light reflex (PLR) alterations following cannabis use healthy in adults. The main question it aims to answer is:
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.
- Conditions
- Cannabis Intoxication, Drug Effects
- Being tested
- Tetrahydrocannabinol (10 mg), Tetrahydrocannabinol (25 mg), Pupillary Light Reflex (PLR) Test, Pupillometer
- Keywords
- Pupillometer, Cannabis Use, Drug Effects, SOBEREYE, OPTOVERA, Pupillary Light Reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetrahydrocannabinol (10 mg)Drug
10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule
Tetrahydrocannabinol (25 mg)Drug
25 mg of THC provided as a softgel capsule.
Pupillary Light Reflex (PLR) TestDiagnostic test
SOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR)
PupillometerDiagnostic test
NeuroLight is an automated pupillometer that generates a flash of light and measures the photomotor reflex very accurately.
| Study group | Role | What they receive |
|---|---|---|
| Tetrahydrocannabinol (10 mg) | Experimental | 10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule. Receives: Drug: Tetrahydrocannabinol (10 mg); Diagnostic Test: Pupillary Light Reflex (PLR) Test; Diagnostic Test: Pupillometer |
| Tetrahydrocannabinol (25 mg) | Experimental | 25 mg of THC provided as a softgel capsule. Receives: Drug: Tetrahydrocannabinol (25 mg); Diagnostic Test: Pupillary Light Reflex (PLR) Test; Diagnostic Test: Pupillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in change in Pupillary Light Reflex (PLR) measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.
Measured: T=0 to T=5 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=30 min.
Measured: T=0 to T=30 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=60 min.
Measured: T=0 to T=60 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=120 min.
Measured: T=0 to T=120 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=180 min.
Measured: T=0 to T=180 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=240 min.
Measured: T=0 to T=240 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=300 min.
Measured: T=0 to T=300 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=360 min.
Measured: T=0 to T=360 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=420 min.
Measured: T=0 to T=420 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=480 min.
Measured: T=0 to T=480 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.
Measured: T=0 to T=5 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=30 min.
Measured: T=0 to T=30 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=60 min.
Measured: T=0 to T=60 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=120 min.
Measured: T=0 to T=120 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=180 min.
Measured: T=0 to T=180 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=240 min.
Measured: T=0 to T=240 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=300 min.
Measured: T=0 to T=300 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=360 min.
Measured: T=0 to T=360 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=480 min.
Measured: T=0 to T=480 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.
Measured: T=0 to T=5 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=30 min.
Measured: T=0 to T=30 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=60 min.
Measured: T=0 to T=60 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=120 min.
Measured: T=0 to T=120 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=180 min.
Measured: T=0 to T=180 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=240 min.
Measured: T=0 to T=240 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=300 min.
Measured: T=0 to T=300 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=360 min.
Measured: T=0 to T=360 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=480 min.
Measured: T=0 to T=480 minutes
Secondary outcomes (18)
The difference in change in reaction time
The difference in change in reaction time as assessed by Dynavision from T= 0 at T=60 minutes
Measured: T= 0 at T=60 minutes
The difference in change in reaction time
The difference in change in reaction time as assessed by Dynavision from T= 0 at T=120 min
Measured: T= 0 at T=120 minutes
The difference in change in reaction time
The difference in change in reaction time as assessed by Dynavision from T= 0 at T=180 minutes
Measured: T= 0 at T=180 minutes
The difference in change in reaction time
The difference in change in reaction time as assessed by Dynavision from T= 0 at T=240 minutes
Measured: T= 0 at T=240 minutes
The difference in change in reaction time
The difference in change in reaction time as assessed by Dynavision from T= 0 at T=300 minutes
Measured: T= 0 at T=300 minutes
The difference in change in reaction time
The difference in change in reaction time as assessed by Dynavision from T= 0 at T=360 min
Measured: T= 0 at T=360 minutes
The difference in change in reaction time
The difference in change in reaction time as assessed by Dynavision from T= 0 at T=420 min
Measured: T= 0 at T=420 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T= 5 min, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T= 5 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=30 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=30 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=60 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=60 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=90 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=90 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=120 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=120 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=180 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=180 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=240 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=240 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=300 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=300 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=360 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=360 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=420 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=420 minutes
The difference in change in subjective drug effects
The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=480 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.
Measured: T=0 at T=480 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start27 May 2025
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sobereye Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967051
- Sponsor's protocol ID
- 24SICFP01
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study Evaluating the Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults
- ClinicalTrials.gov ID
- NCT06967051
- Acronym / sponsor ID
- 24SICFP01
- Conditions
- Cannabis Intoxication, Drug Effects
- Keywords
- Pupillometer, Cannabis Use, Drug Effects, SOBEREYE, OPTOVERA, Pupillary Light Reflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sobereye Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 27 May 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this open label study is to evaluate the efficacy of smart phone-based test (SOBEREYE OPTOVERA) on measuring pupillary light reflex (PLR) alterations following cannabis use healthy in adults. The main question it aims to answer is:
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label pilot study
| Arm | Type | Receives |
|---|---|---|
| Tetrahydrocannabinol (10 mg) | Experimental | Drug: Tetrahydrocannabinol (10 mg), Diagnostic Test: Pupillary Light Reflex (PLR) Test, Diagnostic Test: Pupillometer10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule. |
| Tetrahydrocannabinol (25 mg) | Experimental | Drug: Tetrahydrocannabinol (25 mg), Diagnostic Test: Pupillary Light Reflex (PLR) Test, Diagnostic Test: Pupillometer25 mg of THC provided as a softgel capsule. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females 21 years of age or older
- 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:
- 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
- Self-reported cannabis use at least 3x per month but no more than 3x per week
Key exclusion criteria (23 listed)
- Individuals who are pregnant, breast feeding or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption study products
- 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)
- History of surgery on eyes or retinas except for laser corneal surgery
- Current or history of psychological disorders (e.g., schizophrenia and psychosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetrahydrocannabinol (10 mg)10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule | Drug | Tetrahydrocannabinol (10 mg) |
| Tetrahydrocannabinol (25 mg)25 mg of THC provided as a softgel capsule. | Drug | Tetrahydrocannabinol (25 mg) |
| Pupillary Light Reflex (PLR) TestSOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR) | Diagnostic test | Tetrahydrocannabinol (10 mg), Tetrahydrocannabinol (25 mg) |
| PupillometerNeuroLight is an automated pupillometer that generates a flash of light and measures the photomotor reflex very accurately. | Diagnostic test | Tetrahydrocannabinol (10 mg), Tetrahydrocannabinol (25 mg) |
Primary outcome
The difference in change in Pupillary Light Reflex (PLR) measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=5 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=30 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=30 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=60 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=60 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=120 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=120 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=180 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=180 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=240 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=240 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=300 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=300 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=360 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=360 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=420 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=420 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=480 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=480 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=5 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=30 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=30 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=60 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=60 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=120 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=120 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=180 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=180 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=240 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=240 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=300 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=300 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=360 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=360 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=480 minutes
The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=480 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=5 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=30 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=30 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=60 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=60 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=120 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=120 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=180 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=180 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=240 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=240 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=300 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=300 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=360 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=360 min.
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer
Time frame: T=0 to T=480 minutes
The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=480 min.
18 secondary outcomes
The difference in change in reaction time
Time frame: T= 0 at T=60 minutes
The difference in change in reaction time
Time frame: T= 0 at T=120 minutes
The difference in change in reaction time
Time frame: T= 0 at T=180 minutes
The difference in change in reaction time
Time frame: T= 0 at T=240 minutes
The difference in change in reaction time
Time frame: T= 0 at T=300 minutes
The difference in change in reaction time
Time frame: T= 0 at T=360 minutes
The difference in change in reaction time
Time frame: T= 0 at T=420 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T= 5 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=30 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=60 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=90 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=120 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=180 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=240 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=300 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=360 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=420 minutes
The difference in change in subjective drug effects
Time frame: T=0 at T=480 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetrahydrocannabinol (10 mg), Tetrahydrocannabinol (25 mg) and Pupillary Light Reflex (PLR) Test in people with Cannabis Intoxication and Drug Effects, run by Sobereye Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in Pupillary Light Reflex (PLR) measures between a smart phone-based test and NeuroLight pupillometer (time frame: T=0 to T=5 minutes). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.