Health TrialsbyHealthPanel

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

ConditionsCannabis IntoxicationDrug Effects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSobereye Inc.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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) Test

    Diagnostic test

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

  • Pupillometer

    Diagnostic test

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Tetrahydrocannabinol (10 mg)Experimental treatment 3 interventions
Group B: Tetrahydrocannabinol (25 mg)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
T=0 to T=5 minutes
2

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.

Time frame
T=0 to T=30 minutes
3

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.

Time frame
T=0 to T=60 minutes
4

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.

Time frame
T=0 to T=120 minutes

Secondary outcomes

1

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

Time frame
T= 0 at T=60 minutes
2

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

Time frame
T= 0 at T=120 minutes
3

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

Time frame
T= 0 at T=180 minutes
4

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

Time frame
T= 0 at T=240 minutes

Other outcomes

1

Clinically relevant post-emergent adverse events

Clinically relevant post-emergent adverse events at T=0 to T=480 minutes. Including via 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.

Time frame
T=0 to T=480 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sobereye Inc.

Lead sponsor

KGK Science Inc.

Collaborator

Source ClinicalTrials.gov
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