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Trial registered on ANZCTR


Registration number
ACTRN12619001103156p
Ethics application status
Not yet submitted
Date submitted
26/07/2019
Date registered
9/08/2019
Date last updated
13/08/2019
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of novel medicinal cannabis formulation IHL-42X on apnoea hypopnea index in adults with suspected or diagnosed mild to moderate obstructive sleep apnoea.
Scientific title
A Phase 2a randomised controlled trial measuring the effects on apnoea hypopnoea index (AHI) with nocturnal IHL-42X versus placebo in adults with obstructive sleep apnoea (OSA)
Secondary ID [1] 298852 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 313805 0
Condition category
Condition code
Respiratory 312215 312215 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active treatment contains a novel formulation of 10mg of a synthetic (-) -trans-delta-9-tetrahydrocannabinol (THC) with 200mg mineral supplement combination.
The blinded study treatment will be provided as capsules in coded blister packs labelled with the expiry date, contact details for the Principal Investigator, as well as storage and administration instructions. Participants will be instructed to self-administer two capsules by mouth, 60 minutes before bedtime for each night of the study duration (5-10 days for phase 1, 42 days for phase 2).
After eligibility is verified post- V1 the participants will be supplied with the 6 weeks supply of the treatment, with the blister packs grouped into 14 days’ supply, each with 4 reserve doses to allow for ± 2 day window each week to replace lost or damaged dose units. Participants will be required to return all unused study medication and blister packs at V2, as well as the treatment compliance log which they will be instructed to complete daily. Treatment adherence will also be checked at the three telephone interviews that will take place between V1 and V2 (days 10, 20 and 30).

Both the active treatment and the placebo are identical in appearance. Treatments will be provided as capsules in blister packs with the participant identification number and contact details for the principal investigator, clearly labelled by a disinterested third party. Until dispensed to the participants, the trial products will be stored in a securely locked, refrigerated area, only accessible to authorized personnel.
Intervention code [1] 315118 0
Treatment: Drugs
Comparator / control treatment
The placebo capsules will be identical in appearance to the active capsules but will not contain the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 320855 0
Apnoea Hypopnea Index measured using overnight polysomnography
Timepoint [1] 320855 0
6 weeks post first dose
Secondary outcome [1] 373065 0
Daytime somnolence measured using the Epworth Sleepiness Scale
Timepoint [1] 373065 0
6 weeks post first dose
Secondary outcome [2] 373066 0
Subjective sleep quality measured using the Leeds Sleep Evaluation Questionnaire
Timepoint [2] 373066 0
6 weeks post first dose
Secondary outcome [3] 373067 0
Mood measured using the Profile of Mood States
Timepoint [3] 373067 0
6 weeks post first dose
Secondary outcome [4] 373068 0
Well-being measured using the Short Form 36
Timepoint [4] 373068 0
6 weeks post first dose
Secondary outcome [5] 373069 0
Subjective sleep quality measured using the Pittsburgh Sleep Quality Index
Timepoint [5] 373069 0
6 weeks post first dose
Secondary outcome [6] 373070 0
Subjective insomnia severity measured using the Insomnia Severity Index
Timepoint [6] 373070 0
6 weeks post first dose
Secondary outcome [7] 373071 0
Subjective symptoms measured using a visual analogue scale
Timepoint [7] 373071 0
6 weeks post first dose
Secondary outcome [8] 373072 0
Subjective sleep quality measured using the Consensus Sleep Diary
Timepoint [8] 373072 0
6 weeks post first dose
Secondary outcome [9] 373073 0
Depression symptoms measured using the Beck Depression Inventory
Timepoint [9] 373073 0
6 weeks post first dose
Secondary outcome [10] 373074 0
Anxiety symptoms measured using the Beck Anxiety Inventory
Timepoint [10] 373074 0
6 weeks post first dose
Secondary outcome [11] 373075 0
Daytime somnolence measured using the Epworth Sleepiness Scale
Timepoint [11] 373075 0
10 days post first dose
Secondary outcome [12] 373076 0
Daytime somnolence measured using the Epworth Sleepiness Scale
Timepoint [12] 373076 0
20 days post first dose
Secondary outcome [13] 373077 0
Daytime somnolence measured using the Epworth Sleepiness Scale
Timepoint [13] 373077 0
30 days post first dose
Secondary outcome [14] 373078 0
Subjective sleep quality measured using the Leeds Sleep Evaluation Questionnaire
Timepoint [14] 373078 0
10 days post first dose
Secondary outcome [15] 373079 0
Subjective sleep quality measured using the Leeds Sleep Evaluation Questionnaire
Timepoint [15] 373079 0
20 days post first dose
Secondary outcome [16] 373080 0
Subjective sleep quality measured using the Leeds Sleep Evaluation Questionnaire
Timepoint [16] 373080 0
30 days post first dose
Secondary outcome [17] 373081 0
Mood measured using the Profile of Mood States
Timepoint [17] 373081 0
10 days post first dose
Secondary outcome [18] 373082 0
Mood measured using the Profile of Mood States
Timepoint [18] 373082 0
20 days post first dose
Secondary outcome [19] 373083 0
Mood measured using the Profile of Mood States
Timepoint [19] 373083 0
30 days post first dose
Secondary outcome [20] 373084 0
Well-being measured using the Short Form 36
Timepoint [20] 373084 0
10 days post first dose
Secondary outcome [21] 373085 0
Well-being measured using the Short Form 36
Timepoint [21] 373085 0
20 days post first dose
Secondary outcome [22] 373086 0
Well-being measured using the Short Form 36
Timepoint [22] 373086 0
30 days post first dose
Secondary outcome [23] 373087 0
Subjective sleep quality measured using the Pittsburgh Sleep Quality Index
Timepoint [23] 373087 0
10 days post first dose
Secondary outcome [24] 373088 0
Subjective sleep quality measured using the Pittsburgh Sleep Quality Index
Timepoint [24] 373088 0
20 days post first dose
Secondary outcome [25] 373089 0
Subjective sleep quality measured using the Pittsburgh Sleep Quality Index
Timepoint [25] 373089 0
30 days post first dose
Secondary outcome [26] 373090 0
Subjective insomnia severity measured using the Insomnia Severity Index
Timepoint [26] 373090 0
10 days post first dose
Secondary outcome [27] 373091 0
Subjective insomnia severity measured using the Insomnia Severity Index
Timepoint [27] 373091 0
20 days post first dose
Secondary outcome [28] 373092 0
Subjective insomnia severity measured using the Insomnia Severity Index
Timepoint [28] 373092 0
30 days post first dose
Secondary outcome [29] 373093 0
Subjective symptoms measured using a visual analogue scale
Timepoint [29] 373093 0
10 days post first dose
Secondary outcome [30] 373094 0
Subjective symptoms measured using a visual analogue scale
Timepoint [30] 373094 0
20 days post first dose
Secondary outcome [31] 373095 0
Subjective symptoms measured using a visual analogue scale
Timepoint [31] 373095 0
30 days post first dose
Secondary outcome [32] 373096 0
Depression symptoms measured using the Beck Depression Inventory
Timepoint [32] 373096 0
10 days post first dose
Secondary outcome [33] 373097 0
Depression symptoms measured using the Beck Depression Inventory
Timepoint [33] 373097 0
20 days post first dose
Secondary outcome [34] 373098 0
Depression symptoms measured using the Beck Depression Inventory
Timepoint [34] 373098 0
30 days post first dose
Secondary outcome [35] 373099 0
Anxiety symptoms measured using the Beck Anxiety Inventory
Timepoint [35] 373099 0
10 days post first dose
Secondary outcome [36] 373100 0
Anxiety symptoms measured using the Beck Anxiety Inventory
Timepoint [36] 373100 0
20 days post first dose
Secondary outcome [37] 373101 0
Anxiety symptoms measured using the Beck Anxiety Inventory
Timepoint [37] 373101 0
30 days post first dose

Eligibility
Key inclusion criteria
• Aged between 21 and 65 years
• Evidence of an Apnoea Hypopnea Index greater than or equal to 15 or less than or equal to 50. This criteria will be subject to the potential participant either being recently referred to the Austin sleep laboratory for ‘likely OSA’ or having a pre-existing diagnosis of OSA from a physician. This will be verified by the results of the PSG post V1, before randomisation occurs.
• Have experimented with cannabinoids previously (self-disclosure). This includes any cannabis product (marijuana, skunk, ‘weed’)
• No known allergic reaction to cannabis products with previous use
• Ability to speak and read English
• Have no history of past substance abuse or current abuse of illicit drugs
• Physically well with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders
• Not currently pregnant or lactating
• Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne).
• Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
• Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
• Willing to abstain from driving a vehicle for the duration of the study (minimum 6 weeks)
• Willing to self-administer two capsules by mouth, 60 minutes before bedtime, each night for the duration of the study
• Willing to complete a drug-administration log daily throughout participation
• Willing to undergo three phone interviews throughout the duration of the study
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Aged under 21 or over 65 years
• AHI of under 15 or over 50, or no doctors referral or diagnosis of sleep disorder
• Other pre-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.)
• Currently using a positive airway pressure device (e.g. CPAP, VPAP), or other treatment for OSA including mandibular advancement splint, or positional device
• BMI > 45
• ESS < 7 (excludes non-sleepy participants)
• Inability to speak or read English
• Non-compliance with study treatment following placebo run-in (missing greater than 20% of the treatment doses)
• History of drug or substance abuse or current illicit drug abuse
• Not physically well, or a history of severe psychiatric, cardiac, endocrine, renal, gastrointestinal, or bleeding disorders
• Currently pregnant or breastfeeding
• Currently taking medication (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne)
• Severe depression (a cut off of 20 and higher on the BDI)
• Severe anxiety (a cut off of 16 and higher on the BAI).
• No previous experience with cannabinoids
• Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit

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)
Allocation will be concealed by sealed opaque envelopes, which are to be kept in a locked ling cabinet in the Principal Investigator's office and will only be opened in the case of an emergency. In addition, the full randomisation list will be kept in a password protected document in a restricted access confidential folder on a secure server. Only the person who is responsible for generating the randomisation list (a disinterested third party) will have the password to access this document.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of the order of treatment visits will be determined by random allocation by a disinterested third party. All consenting participants will be assigned a participant number. The randomisation order that has been placed next to the participants’ number will be the allocated treatment order for that individual using publicly available randomisation software (Research Randomiser Software Version 4.0).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The purpose of this trial is to investigate the effects of nocturnal IHL-42X on apnoea hypopnea index, sleep quality and mood in healthy adults.
This will be a 6- week, double-blind, placebo controlled randomised trial in patients with suspected or diagnosed mild to moderate Obstructive Sleep Apnoea (OSA) with 3 visits in total (V0, V1 and V2). V0 will be the screening visit. V1 will be the first overnight polysomnography test (PSG), V2 will be 6 weeks later, this will be the second and final PSG. Randomisation and treatment commencement will occur up to 5 business days following V1, once verification of AHI is complete. In between treatment commencement and V2, participants will be contacted by phone three times (10 days post treatment commencement, 20 days post, and 30 days post) to complete a structured phone interview comprised of several questionnaires. Participants will receive their randomised treatment (either IHL-42X, or a placebo) a minimum of 2 business days following V1. They will take the treatment capsules once per day, 60 minutes before bedtime.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical tests will be performed two tailed at the 5% significance level and performed using IBM SPSS statistical package. Z scores for the distribution will be calculated for each variable and displayed in histogram form. Out of range values will be recoded as missing values.
Results for the PSG (AHI) and from the sleep quality/ length/ well-being measures will also be compared using a mixed design analysis of covariance (MANCOVA), with treatment group as the between-subject variable, time as the within-subjects variable, and baseline score as the covariate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
13/05/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303400 0
Commercial sector/Industry
Name [1] 303400 0
Cannvalate
Country [1] 303400 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cannvalate
Address
C2 Level 1/459 Toorak Rd,
Toorak VIC 3142
Country
Australia
Secondary sponsor category [1] 303442 0
None
Name [1] 303442 0
Address [1] 303442 0
Country [1] 303442 0
Other collaborator category [1] 280870 0
Hospital
Name [1] 280870 0
Austin Health
Address [1] 280870 0
145 Studley Road
PO Box 5555
Heidelberg Victoria 3084
Country [1] 280870 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303929 0
Austin Hospital Human Research Ethics Committee
Ethics committee address [1] 303929 0
Ethics committee country [1] 303929 0
Australia
Date submitted for ethics approval [1] 303929 0
18/09/2019
Approval date [1] 303929 0
Ethics approval number [1] 303929 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95290 0
A/Prof Luke Downey
Address 95290 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 95290 0
Australia
Phone 95290 0
+61 3 9214 5781
Fax 95290 0
Email 95290 0
[email protected]
Contact person for public queries
Name 95291 0
Sarah Catchlove
Address 95291 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 95291 0
Australia
Phone 95291 0
+61 3 9214 5483
Fax 95291 0
Email 95291 0
[email protected]
Contact person for scientific queries
Name 95292 0
Luke Downey
Address 95292 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 95292 0
Australia
Phone 95292 0
+61 3 9214 5781
Fax 95292 0
Email 95292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results of this trial will be disseminated via peer-reviewed publications and at academic conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identied raw data will be uploaded to an appropriate repository. Otherwise, as the Intellectual Property of this study are owned by the sponsor and may be used for the purposes of commercialisation of the study product, the trial data will not be made available.


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.