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Recruiting
View on ClinicalTrials.gov

Comparing Tetrahydrocannabinol (10 mg) with Tetrahydrocannabinol (25 mg) for cannabis intoxication

Official title: The Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults

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

Condition: Cannabis IntoxicationSponsor: Sobereye Inc.Target enrollment: 20
  • 2 groups
  • One site, in London
  • Recruiting
KGK Science Inc., London, Ontario

Interventions (4)

  • Medication

    Tetrahydrocannabinol (10 mg)

    10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule

  • Medication

    Tetrahydrocannabinol (25 mg)

    25 mg of THC provided as a softgel capsule.

  • Other intervention

    Pupillary Light Reflex (PLR) Test

    SOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR)

Canadian Sites (1)

1 of 1 recruiting

  • KGK Science Inc.

    London, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for37 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Individuals of child-bearing potential must have a negative baselineBaselineYour starting measurements, taken before treatment begins.Read more → urine pregnancy test and agree to use a medically approved method of birth controlControl groupThe group a new treatment is measured against.Read more → 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:
  • +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → Or,
  • +Double-barrier method
  • +Intrauterine devices
  • +Vasectomy of partner at least 6 months prior to screening
  • +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study
  • +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)
  • +Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
  • +Abstinence and agrees to use contraception if planning on becoming sexually active during the study

Exclusion

  • Allergy, sensitivity, intolerance, or dietary restriction preventing consumption study products
  • Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  • 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)
  • 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
  • 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
  • Individuals with an unstable autoimmune disease
  • 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-InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
  • 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 baselineBaselineYour starting measurements, taken before treatment begins.Read more →, as assessed by the QI
  • Individuals who are cognitively impaired and/or who are unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • 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
  • Individuals who are pregnant, breast feeding or planning to become pregnant during the study
  • History of surgery on eyes or retinas except for laser corneal surgery
  • 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 upFollow-upContinued check-ins after the treatment part is finished.Read more → that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to identify or measure a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Tetrahydrocannabinol (10 mg), together with one or more of: Pupillary Light Reflex (PLR) Test and Pupillometer.

Registry label: A: Tetrahydrocannabinol (10 mg)

Group B receives Tetrahydrocannabinol (25 mg), together with one or more of: Pupillary Light Reflex (PLR) Test and Pupillometer.

Registry label: B: Tetrahydrocannabinol (25 mg)

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 21 years, with no upper limit given.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 20 people.

The study is currently expected to finish around August 2025.

The main measurement is taken over: T=0 to T=5 minutes.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

The difference in change in Pupillary Light Reflex (PLR) measures between a smart phone-based test and NeuroLight pupillometer — measured over T=0 to T=5 minutes.

The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer — measured over T=0 to T=30 minutes.

The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer — measured over T=0 to T=60 minutes.

The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer — measured over T=0 to T=120 minutes.

The study lists 24 further main measurements.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06967051 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Tetrahydrocannabinol (10 mg)Drug

10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Tetrahydrocannabinol (25 mg)Drug

25 mg of THC provided as a softgel capsule.

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Pupillary Light Reflex (PLR) TestDiagnostic test

SOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR)

From the trial registry — its own words, unedited.

What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.

Read the full explanation → · in clinical review

About PupillometerDiagnostic test

NeuroLight is an automated pupillometer that generates a flash of light and measures the photomotor reflex very accurately.

From the trial registry — its own words, unedited.

What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 21 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 21 years, with no upper limit given.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: T=0 to T=5 minutes.

The study as a whole is currently expected to finish around 2025-08.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 20 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: London, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.