Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT05121506
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males and females between 25-65 years of age at screening
2. Body Mass Index (BMI) from 18.5 to 29.9 kg/m2, inclusive
3. Occasional users of cannabis: Have consumed cannabis products at least once in the past 6 months and at least 4 times in their lifetime but no more than 3 times per week and not within 48 hours of Visit 2 and have experienced psychotropic effects without severe adverse events (short term paranoia, belligerence, extreme hallucinations) requiring medical interventions. Eligibility will be determined on a case by case basis by the QI
4. Female participant is not of child bearing potential, which is defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have undergone natural menopause (have not had menses for \> 1 year) OR
Females of childbearing potential must agree to abstain from heterosexual intercourse or use two methods of contraception for 30 days prior to first treatment and for 30 days after the treatment. Subjects must have a negative urine pregnancy test result at screening and baseline. 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 or agrees to use contraception if planning on changing to heterosexual partner(s)
5. Vasectomy of partner at least 6- months prior to screening
5. A male participant with sexual partners who are not pregnant or do not fit the criteria as indicated above in number 4 must meet the following criteria
* Participant is unlikely to procreate, defined as surgically sterile (i.e. has undergone vasectomy, it must be at least 6 months since the surgery)
* Participant agrees to use of the accepted contraceptive regimens from first drug administration until 30 days after the drug administration
* An acceptable method of contraception includes one of the following:
* Abstinence from heterosexual intercourse
* Condom with spermicide
6. Agrees to avoid alcohol intake 48 h prior to visit 2
7. Agrees to avoid tobacco or nicotine-containing products 96 hours prior to visit 2
8. Healthy as determined by medical history and laboratory results, as assessed by the QI
9. Agrees to complete all study related procedures and assessments
10. Agrees to provide information of two adult contacts to be reached in the event of transportation requirements from the clinic to their home after the study visits
11. Provides voluntary, written informed consent to participate in the study
Exclusion Criteria:
1. Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
2. Allergy or sensitivity to investigational product's active or inactive ingredients
3. Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or dermatological conditions (open wounds, scars, sunburns, moles) in the proposed area of application that would interfere with the application and absorption of the test product
4. Shaving, waxing or laser hair removal of the planned study treatment application area within 14 days prior to baseline. Tattoos on the planned study application area.
5. Current use of prescribed medication containing the ingredients in the IP
6. Current use of over-the-counter medications, supplements, and foods/drinks containing the ingredients in the IP unless willing to washout
7. Prescribed or OTC medication, supplements, or food/drinks that will interact with the investigational product
8. Positive drug of abuse test at baseline
9. History of alcohol and/or drug abuse or substance dependence within the last 12 months
10. High alcohol intake (average of \>2 standard drinks per day)
11. Self-reported serious psychological disorder(s) diagnosis e.g. schizophrenia, bipolar disorder, depression, PTSD, sleep disorder that, in the QI's opinion, could interfere with study participation. History of suicidal ideation, attempts and/or behaviour.
12. History of psychosis in immediate family including schizophrenia and affective psychosis
13. Cancer, except basal cell skin 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
14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
15. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
16. Self-reported cardiovascular disease. Participants with no significant cardiovascular event in the past 1 year and who are on stable medication may be included after assessment by the QI on a case-by-case basis
17. Individuals with an autoimmune disease or who are immune-compromised
18. Positive laboratory results for HIV, Hepatitis B or C as assessed at screening
19. Type I or Type II diabetes
20. Current or history of significant liver disease or dysfunction that in the opinion of the QI may impact study outcomes or participant safety
21. History of or current diagnosis with kidney diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months
22. Self-reported current or pre-existing thyroid condition. Treatment on a stable dose medication for over 6 months will be reviewed on a case-by-case basis by the QI
23. Self- reported blood/bleeding disorder as assessed by the QI
24. Clinically significant abnormal laboratory results at screening as determined by the QI
25. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
26. Participation in other clinical research trials 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
27. Individuals who are unable to give informed consent
28. 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05121506
Study Brief:
Protocol Section:
NCT05121506