Smartphone App for Cannabis Use

Overseen By Erin Lewis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sobereye Inc.

Must not be taking: Prescribed medications, OTC medications

Disqualifiers: Pregnancy, Neurological issues, Diabetes, Cardiovascular events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

This trial is for healthy adults interested in how cannabis affects their eyes' response to light. Participants will use a smartphone-based test after consuming different doses of THC, the active ingredient in cannabis. They must be willing to take THC and have their pupillary light reflex (PLR) measured.

Inclusion Criteria

I am 21 years old or older.

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

Exclusion Criteria

Individuals with an unstable autoimmune disease

Individuals who are pregnant, breast feeding or planning to become pregnant during the study

Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of study products

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Participants ingest THC capsules and complete PLR tests throughout the study day

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

Treatment Details

Interventions

• Tetrahydrocannabinol

Trial Overview The study tests if SOBEREYE OPTOVERA, a smart phone-based app, can accurately measure changes in PLR after taking THC compared to standard measurements with a pupillometer. Participants will ingest either 10 mg or 25 mg of THC and undergo PLR testing.

Participant Groups

Group I: Tetrahydrocannabinol (25 mg) Experimental Treatment 3 Interventions

25 mg of THC provided as a softgel capsule.

Group II: Tetrahydrocannabinol (10 mg) Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Sobereye Inc.

Lead Sponsor

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution