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Trial registered on ANZCTR
Registration number
ACTRN12622001034729
Ethics application status
Approved
Date submitted
27/06/2022
Date registered
25/07/2022
Date last updated
8/09/2022
Date data sharing statement initially provided
25/07/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Cannabidiol (MC-1020) Oro-buccal Spray Administration Clinical Trial
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Scientific title
Assessing absorption of Cannabidiol (MC-1020) via oro-buccal spray administration in healthy adults
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Secondary ID [1]
307171
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CANNABIDIOL (MC-1020) ORO-BUCCAL ADMINISTRATION STUDY
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
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Condition category
Condition code
Mental Health
324057
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
323624
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Treatment: Drugs
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Comparator / control treatment
No comparator/control treatment will be employed. This study is a single dose open label pharmacokinetic exploratory study investigating the oro-buccal administration of NanoCBD. One actuation of the pump to a single cheek containing a total of 2.5mg CBD
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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Oro-buccal absorption as evidenced by assessing Plasma cannabidiol (CBD) levels at the 50 min time point after a single 2.5 mg and 5 mg CBD dose, respectively.
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Assessment method [1]
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Timepoint [1]
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Blood (5 ml) and sputum (2.5 ml; no pharmacological inducement) will be collected at 50 min after administration of study intervention.
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Primary outcome [2]
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CBD plasma metabolite levels for 7-hydroxy cannabidiol (7-OH-CBD) to indicate adequacy of oro-buccal administration
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Assessment method [2]
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Timepoint [2]
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Blood (5 ml) and sputum (2.5 ml; no pharmacological inducement) will be collected at 50 min after administration of study intervention.
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Secondary outcome [1]
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Assessing the time taken until > 90% of CBD from one spray (2.5 mg CBD) of NanoCBD oro-buccal spray is absorbed into the oro-buccal mucosa by drinking water to wash-away excess CBD from the oral cavity and measuring the resultant change in serum CBD levels.
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Assessment method [1]
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Timepoint [1]
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Blood (5 ml) and sputum (2.5 ml); no pharmacological inducement) will be collected at 50 mins after administration of the study intervention.
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Secondary outcome [2]
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Saliva CBD, 7-COOH-CBD and 7-OH-CBD levels will be analysed together as a composite outcome in saliva.
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Assessment method [2]
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Timepoint [2]
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Blood (5 ml) and sputum (2.5 ml; no pharmacological inducement) will be collected at 50 min after administration of study intervention.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Medlab Clinical
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Address [1]
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Unit 5/11 Lord Street
Botany NSW 2019
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Medlab Clinical
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Address
Unit 5/11 Lord Street
Botany NSW 2019
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
312873
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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National Institute of Integrative Medicine Human Research Ethics Committee
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Ethics committee address [1]
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21 Burwood Rd, Hawthorn VIC 3122
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/04/2022
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Approval date [1]
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31/08/2022
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Ethics approval number [1]
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0105E_2022
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jeremy Henson
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Address
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Medlab Clinical
Unit 5/11 Lord Street
Botany NSW 2019
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Country
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Australia
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Phone
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+61 430448579
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Courtney Fletcher
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Address
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Medlab Clinical
Unit 5/11 Lord Street
Botany NSW 2019
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Country
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Australia
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Phone
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+61 2 81880311
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Luis Vitetta
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Address
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Medlab Clinical
Unit 5/11 Lord Street
Botany NSW 2022
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Country
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Australia
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Phone
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+61 2 81880311
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16127
Study protocol
384092-(Uploaded-29-06-2022-15-10-30)-Study-related document.pdf
16128
Informed consent form
384092-(Uploaded-19-05-2022-10-24-39)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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