None listed
Conditions
Brief summary
This study will explore if it is possible to administer NanoCBD™ (MC_1020) oro-buccal spray so as to reliably achieve mucosal absorption of CBD and to understand some of the factors affecting mucosal absorption of CBD administered with the NanoCBD (MC-1020) oro-buccal spray . Ingested CBD has poor and erratic bioavailability and is subject to up to 75% first-pass metabolism, which could be improved by oro-buccal delivery. However, attempts at oro-buccal delivery to-date have failed as evident from the high levels of first pass metabolites present in the plasma. Preliminary data from micellized cannabinoid oro-buccal sprays indicate that the NanoCelle™ technology used to create these cannabinoid micelles, may be able to facilitate oro-buccal mucosa absorption; however, successful administration has been inconsistent. If reliable oro-buccal mucosa absorption can be demonstrated and the critical factors for achieving this is better understood, a delivery mechanism for cannabinoids that is suitable for routine medical use could be provided.
Interventions
MC-1020 is a Hemp Oil Extract (16.67 mg/mL Cannabidiol) formulated in anano-micellular suspension for oro-buccal administration. One actuation of the pump delivers 150 microlitres, which contains 2.5 mg CBD. Two actuation of the pump (one on each cheek) containing a total of 5mg CBD).
One actuation of the pump delivers 150 µL, which contains 2.5 mg CBD. For multiple sprays, alternate cheeks will be used with a 2-minute wait before applying to the same cheek.
Participants will receive a single
MC-1020 is a Hemp Oil Extract (16.67 mg/mL Cannabidiol) formulated in anano-micellular suspension for oro-buccal administration. One actuation of the pump delivers 150 microlitres, which contains 2.5 mg CBD. Two actuation of the pump (one on each cheek) containing a total of 5mg CBD). One actuation of the pump delivers 150 µL, which contains 2.5 mg CBD. For multiple sprays, alternate cheeks will be used with a 2-minute wait before applying to the same cheek. Participants will receive a single dose of 2.5mg (1 actuation of the pump) or 5mg (2 actuations of pump) of CBD once only. The first 5 participants who enrol will receive 2.5mg and the next cohort of 5 participants will receive 5mg. Participants will be instructed on how to administer MC-1020, including alternating cheeks for more than one spray per dose, dosing while at rest (sitting) and without talking. Participants will self-administer the intervention under the supervision of a research team member. The assessment will be undertaken by a physician investigator with a Research Coordinator / Nurse assistant to the PI. They will record the information experienced by the participant including all adverse experiences such as reported from common cannabis treatment-related adverse events, including most mild to moderate severity AEs, psychosis, somnolence, dizziness, confusion, vomiting, hypotension, blurred vision, drowsiness, dry eyes, visual hallucinations, relaxation, coordination disturbance, euphoria, headache, and nausea.
Sponsors
Medlab Clinical
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
i. Male or female outpatients 18-85 years of age. ii. Physically and mentally healthy and not currently taking any medications, vitamins, minerals, supplements or any other cannabis based products. iii. The ability to comprehend and satisfactorily comply with protocol requirements. iv. Written informed consent given prior to entering the baseline period of the study.
Exclusion criteria
i. Any past history of schizophrenia, psychosis, bipolar disorder or major depression. Or any immediate family history of psychosis. ii. Acute suicidality. iii. History or substantial risk of heart disease (arrhythmia, ischaemic heart disease, heart failure). iv. Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant. Estrogen-based oral contraceptives are not considered reliable forms of contraception during this study due to drug interaction with CBD. v. Participants who have a history of contraindications or adverse reactions to cannabis. vi. Unable to comply with study procedures or assessments. vii. The current use of any dietary and herbal supplements (15 days wash-out period required); viii. The current use of any over-the-counter or prescription medications.
Outcome results
None listed