Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000868886p
Ethics application status
Not yet submitted
Date submitted
14/04/2021
Date registered
6/07/2021
Date last updated
6/07/2021
Date data sharing statement initially provided
6/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Trial on The Bioavailability and Half-Life of Sublingually Administered Cannabis Products in Healthy People
Scientific title
A Phase I Trial on The Bioavailability and Half-Life of Sublingually Administered Cannabis Products in Healthy People
Secondary ID [1] 303883 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 321460 0
Condition category
Condition code
Mental Health 319222 319222 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1: Single dose sublingually 2ml administration of a cannabis tincture containing 50mg Cannabidiol (CBD) and 1.9mg delta-9-Tetrahydrocannabinol (THC) per ml in solution with MCT oil. Participants must hold the tincture under their tongue for 60 seconds before swallowing.

Cohort 2: Single dose sublingually 2ml administration of a cannabis tincture containing 0mg CBD and 2.5mg THC per ml in solution with MCT oil. Participants must hold the tincture under their tongue for 60 seconds before swallowing.
Intervention code [1] 320228 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327138 0
Single dose pharmacokinetic assessment of cannabis tinctures using GC/MS analysis of blood serum samples (4ml)

Measures will be Cmax, Tmax, AUC, and elimination half-life.
Timepoint [1] 327138 0
Initial blood sample will be taken immediately prior to administration of the study drug(T+0). Further samples will be taken at T+ 30, T+60, T+120, T+180, T+240, T+300, T+360, and T+420 minutes post administration.
Secondary outcome [1] 393972 0
Change in working memory performance overtime after single dose administration of a cannabis product assessed using a N-back test.
Timepoint [1] 393972 0
Initial assessment will be prior to drug administration (T+0). Further assessments will occur at T+60, T+120, T+180, T+240, T+300, T+360, and T+420 minutes post administration.

Secondary outcome [2] 393973 0
Change in simple visual reaction time overtime after single dose administration of a cannabis product assessed using a Go/No-Go test.
Timepoint [2] 393973 0
Initial assessment will be prior to drug administration (T+0). Further assessments will occur at T+60, T+120, T+180, T+240, T+300, T+360, and T+420 minutes post administration.
Secondary outcome [3] 393974 0
Change in motor impairment after single dose administration of a cannabis product assessed using a 20 metre straight line walk test.
Timepoint [3] 393974 0
Initial assessment will be prior to drug administration (T+0). Further assessments will occur at T+60, T+120, T+180, T+240, T+300, T+360, and T+420 minutes post administration.
Secondary outcome [4] 393975 0
Change in self-rated perceived level of intoxication overtime after single dose administration of a cannabis product assessed using a 10 millimetre visual analogue scale.
Timepoint [4] 393975 0
Assessed at T+60, T+120, T+180, T+240, T+300, T+360, and T+420 minutes post administration.

The average self-perceived levels of intoxication will compared between Arm 1 and Arm 2 participants at each time piont

Eligibility
Key inclusion criteria
The key exclusion criteria are:
*Willing and able to give informed consent and be between 25 and 75 years of age
*Willing and able to commit to a full day eight hour experiment session
*Willing and able to attend therapy sessions once a month and complete other assessments when required
*If applicable be willing and able to provide evidence of a negative pregnancy test taken no more than 72 hours prior to participating in the study
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The key exclusion criteria are:
*Any family or personal history of psychosis
*Any history of cardiovascular disorders
*Currently taking any other medications (other than birth control)
*Must not be taking any herbal remedies e.g. Saint John's Wort
*Any diagnosis of a DSM-V qualifying condition
*Have any other current health condition that requires pharmaceutical treatment.
*Participants must not have used any other cannabis product for at least one month prior to study entry or use any other cannabis product during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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
23/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 23594 0
New Zealand
State/province [1] 23594 0

Funding & Sponsors
Funding source category [1] 308275 0
Commercial sector/Industry
Name [1] 308275 0
Soma Group Limited
Country [1] 308275 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Soma Group Limited
Address
63 Mandeville Street
Riccarton
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 309130 0
None
Name [1] 309130 0
Address [1] 309130 0
Country [1] 309130 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308251 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308251 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 308251 0
New Zealand
Date submitted for ethics approval [1] 308251 0
07/07/2021
Approval date [1] 308251 0
Ethics approval number [1] 308251 0
Ethics committee name [2] 308294 0
Standing Committee on Therapeutic Trials
Ethics committee address [2] 308294 0
Health Research Council
Level 3/110 Stanley Street,
Grafton,
Auckland 1010
Ethics committee country [2] 308294 0
New Zealand
Date submitted for ethics approval [2] 308294 0
07/07/2021
Approval date [2] 308294 0
Ethics approval number [2] 308294 0

Summary
Brief summary
This trial will investigate the single dose pharmacokinetics of two sublingually administered cannabis products, one CBD dominant the other THC dominant. This data will be used to inform dosing decisions in other trials. A secondary objective of this trial is to identify at what point do subjects begin to feel the intoxicating effects of these products and for how long they last.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110078 0
Mr Callum Jones
Address 110078 0
Soma Group Ltd
63 Mandeville Street
Riccarton
Christchurch 8011
Country 110078 0
New Zealand
Phone 110078 0
+64278255075
Fax 110078 0
Email 110078 0
c.mchale@somagroup.co.nz
Contact person for public queries
Name 110079 0
Mr Greg Marshall
Address 110079 0
Soma Group Ltd
63 Mandeville Street
Riccarton
Christchurch 8011
Country 110079 0
New Zealand
Phone 110079 0
+6421768884
Fax 110079 0
Email 110079 0
g.marshall@somagroup.co.nz
Contact person for scientific queries
Name 110080 0
Mr Callum Jones
Address 110080 0
Ltd
63 Mandeville Street
Riccarton
Christchurch 8011
Country 110080 0
New Zealand
Phone 110080 0
+64278255075
Fax 110080 0
Email 110080 0
c.mchale@somagroup.co.nz

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?

No Supporting Document Provided


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.