Trial Review

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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
Scientific title
Assessing absorption of Cannabidiol (MC-1020) via oro-buccal spray administration in healthy adults
Secondary ID [1] 307171 0
CANNABIDIOL (MC-1020) ORO-BUCCAL ADMINISTRATION STUDY
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 326843 0
Condition category
Condition code
Mental Health 324057 324057 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323624 0
Treatment: Drugs
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
Control group
Dose comparison

Outcomes
Primary outcome [1] 331420 0
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.
Timepoint [1] 331420 0
Blood (5 ml) and sputum (2.5 ml; no pharmacological inducement) will be collected at 50 min after administration of study intervention.

Primary outcome [2] 331843 0
CBD plasma metabolite levels for 7-hydroxy cannabidiol (7-OH-CBD) to indicate adequacy of oro-buccal administration
Timepoint [2] 331843 0
Blood (5 ml) and sputum (2.5 ml; no pharmacological inducement) will be collected at 50 min after administration of study intervention.
Secondary outcome [1] 409818 0
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.
Timepoint [1] 409818 0
Blood (5 ml) and sputum (2.5 ml); no pharmacological inducement) will be collected at 50 mins after administration of the study intervention.
Secondary outcome [2] 411373 0
Saliva CBD, 7-COOH-CBD and 7-OH-CBD levels will be analysed together as a composite outcome in saliva.
Timepoint [2] 411373 0
Blood (5 ml) and sputum (2.5 ml; no pharmacological inducement) will be collected at 50 min after administration of study intervention.


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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311473 0
Commercial sector/Industry
Name [1] 311473 0
Medlab Clinical
Country [1] 311473 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
Unit 5/11 Lord Street
Botany NSW 2019
Country
Australia
Secondary sponsor category [1] 312873 0
None
Name [1] 312873 0
Address [1] 312873 0
Country [1] 312873 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310939 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 310939 0
21 Burwood Rd, Hawthorn VIC 3122
Ethics committee country [1] 310939 0
Australia
Date submitted for ethics approval [1] 310939 0
20/04/2022
Approval date [1] 310939 0
31/08/2022
Ethics approval number [1] 310939 0
0105E_2022

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119426 0
Dr Jeremy Henson
Address 119426 0
Medlab Clinical
Unit 5/11 Lord Street
Botany NSW 2019
Country 119426 0
Australia
Phone 119426 0
+61 430448579
Fax 119426 0
Email 119426 0
jeremy_henson@medlab.co
Contact person for public queries
Name 119427 0
Miss Courtney Fletcher
Address 119427 0
Medlab Clinical
Unit 5/11 Lord Street
Botany NSW 2019
Country 119427 0
Australia
Phone 119427 0
+61 2 81880311
Fax 119427 0
Email 119427 0
courtney_fletcher@medlab.co
Contact person for scientific queries
Name 119428 0
Prof Luis Vitetta
Address 119428 0
Medlab Clinical
Unit 5/11 Lord Street
Botany NSW 2022
Country 119428 0
Australia
Phone 119428 0
+61 2 81880311
Fax 119428 0
Email 119428 0
luis_vitetta@medlab.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16127Study protocol    384092-(Uploaded-29-06-2022-15-10-30)-Study-related document.pdf
16128Informed 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.