The Efficacy of a Smart Phone-based Test on Measuring Pup... | NCT06967051

Status Module

Name	Class
KGK Science Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Tetrahydrocannabinol (10 mg)	Experimental	10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule.	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.	Drug: Tetrahydrocannabinol (25 mg) Diagnostic Test: Pupillary Light Reflex (PLR) Test Diagnostic Test: Pupillometer

Name	Type	Description	Arm Group Labels	Other Names
Tetrahydrocannabinol (10 mg)	Drug	10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule	Tetrahydrocannabinol (10 mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	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.	T=0 to T=180 minutes
The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

Secondary Outcomes

Measure	Description	Time Frame
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	T= 0 at T=60 minutes
The difference in change in reaction time

Other Outcomes

Measure	Description	Time Frame
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.	T=0 to T=480 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. 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)
2. Double-barrier method
3. Intrauterine devices
4. Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
5. Vasectomy of partner at least 6 months prior to screening
6. 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

Exclusion Criteria:

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
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

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals