BridgeMD
Tests treatment safety and results 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
ClinicalTrials.gov ID: NCT06967051
What this study is testing
What is Tetrahydrocannabinol (10 mg)?
Tetrahydrocannabinol (10 mg) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cannabis intoxication.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable...
- Double-barrier method
- Intrauterine devices
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant...
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- 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...
- 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
- 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...
- 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 how well it works 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
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.