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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app that measures changes in the eye's pupil response to light after cannabis use. The goal is to determine if this app can detect these changes as effectively as a traditional pupillometer. Participants will take either 10 mg or 25 mg of THC (tetrahydrocannabinol, the main psychoactive component of cannabis) and complete pupil tests throughout the day. This trial suits individuals who use cannabis regularly, but not more than three times a week, and are comfortable with THC's effects. As an unphased trial, this study offers an opportunity to contribute to innovative research using technology to enhance cannabis-related health assessments.

Will I have to stop taking my current medications?

The trial requires that you stop using any prescribed or over-the-counter medications, supplements, or foods/drinks that might affect the study's safety or effectiveness. It's best to discuss your specific medications with the study team to see if they are allowed.

What prior data suggests that this smartphone app is safe for measuring pupillary light reflex alterations?

Research has shown that THC, a key component of cannabis, can have various effects on the body and mind. Common side effects include headaches, dry mouth, and red or dry eyes. Some individuals may also experience dizziness or sleepiness, increasing the risk of falls.

THC affects mood and perception, altering feelings and sensory experiences. These effects can vary from person to person.

Although the safety of THC has been extensively studied, individual reactions can still differ based on personal health and dosage. Consider these factors when deciding to join a study involving THC. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Tetrahydrocannabinol (THC) for managing cannabis use because it offers a novel approach by utilizing a component of cannabis itself, potentially helping users manage their consumption more effectively. Unlike traditional treatments that might focus on behavioral therapy or alternative medications to mitigate cannabis use, THC as a treatment is unique because it aims to regulate usage through controlled dosing. With doses provided as a softgel capsule, it allows for precise administration, which could lead to more predictable outcomes and better adherence compared to other methods. This approach may offer new insights into how cannabinoids can be used therapeutically, rather than solely recreationally.

What evidence suggests that the SOBEREYE OPTOVERA app is effective for detecting PLR alterations following cannabis use?

Research has shown that THC, the main ingredient in cannabis, affects brain function, particularly in tasks involving short-term memory. THC's effects on the brain can be observed through changes in physical responses, such as the pupillary light reflex (PLR). Evidence suggests that THC can alleviate medical issues like chemotherapy-induced nausea and pain, but its effects on brain functions remain under study. Understanding these changes can aid in developing tools like the SOBEREYE OPTOVERA app to detect these effects. While THC is known for its medical benefits, research continues on how it alters PLR after cannabis use. Participants in this trial will receive either 10 mg or 25 mg of THC to further explore these effects. ^{6 7 8 9 10}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

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

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

I am 21 years old or older.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK425767/

Therapeutic Effects of Cannabis and Cannabinoids - NCBI - NIH Cannabinoids are effective for chemotherapy-induced nausea/vomiting, chronic pain, and MS-related spasticity. Other conditions have inadequate information.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829657

Brain Function Outcomes of Recent and Lifetime Cannabis ... These findings suggest that cannabis use is associated with short- and long-term brain function outcomes, especially during working memory tasks.

3. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7412a1.htm

Routes of Marijuana Use — Behavioral Risk Factor... In 2022, 15.3% of adults reported current cannabis use, approximately 80% of whom reported smoking. Eating, vaping, and dabbing (inhaling heated concentrated ...

4. samhsa.gov samhsa.gov/substance-use/learn/marijuana/risks

Know the Effects, Risks and Side Effects of Marijuana Research shows that people who use marijuana are more likely to have relationship problems, worse educational outcomes, lower career achievement, and reduced ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1490621/full

Meta-analysis of medical cannabis outcomes and ... Patient-reported outcome measures indicate that 70%–90% of patients who used cannabis to directly treat cancer symptoms reported improvements, ...

6. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/12068m.pdf

Safety Data Sheet Δ9-THC is highly flammable, suspected of damaging fertility, harmful if swallowed, in contact with skin, or inhaled, and causes serious eye ...

7. cdc.gov cdc.gov/cannabis/health-effects/index.html

Cannabis Health Effects Cannabis use may have a wide range of health effects on the body and brain. · There are several risk factors and negative health outcomes ...

8. nida.nih.gov nida.nih.gov/research-topics/cannabis-marijuana

Cannabis (Marijuana) | National Institute on Drug Abuse (NIDA) Cannabis products with THC can cause changes in mood, thoughts, and perceptions of reality. These products can also cause harmful health effects ...

9. fda.gov fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc

5 Things to Know about Delta-8 Tetrahydrocannabinol The FDA received 104 reports of adverse events in patients who consumed delta-8 THC products between December 1, 2020, and February 28, 2022. ...

10. mayoclinic.org mayoclinic.org/drugs-supplements-marijuana/art-20364974

Marijuana Safety and side effects · Headaches. · Dry mouth. · Red and dry eyes. · Dizziness and higher risk of falling. · Drowsiness, including problems ...