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Trial registered on ANZCTR


Registration number
ACTRN12623000870651p
Ethics application status
Not yet submitted
Date submitted
3/04/2023
Date registered
14/08/2023
Date last updated
26/08/2024
Date data sharing statement initially provided
14/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of a cannabis-based medication on sleep problems in chronic pain
Scientific title
Long-term effects of a cannabis-based medication on insomnia in chronic back pain: a randomized crossover trial
Secondary ID [1] 309375 0
none
Universal Trial Number (UTN)
U1111- 1290- 7165
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:


Chronic Pain
 329592 0
Insomnia 329593 0
Condition category
Condition code
Anaesthesiology 326519 326519 0 0
Pain management
Neurological 327543 327543 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, double-blind, placebo-controlled crossover study on the efficacy of the study medication, a NZ-produced Cannabis-Based Medication (CBM) in treating insomnia in patients with chronic back pain. The study will be run over 196 days (84 days per arm) in the Bay of Plenty. The Chief Investigator (CI), a Specialist Pain Medicine Physician (SPMP), will undertake the study, including data collection and analysis.

Investigational Medicinal product (IMP)
Helius THC10:CBD10 Full Spectrum. Oral liquid prescribed in 30 ml bottles with a child-proof lid and a 1 ml graduated oral syringe. The formulation uses a medium-chain triglyceride (MCT) carrier oil.

The subjects will be given one bottle at a time, which will last approximately 30 days. Study participants will be asked to take the medication about one hour before bedtime. Subjects will be asked to start at 0.2 ml and titrate up by 0.2 ml per day to a maximum dose of 1.0 ml per night, with the aim of balancing positive effect of sleep against any adverse effects. The IMP will be stored with Helius or study pharmacy before dispensing to participants.

Procedure
Participants will be provided with an actigraphic device (Motion watch 8- CamNtech) for the duration of the study, which will be used to assess objective sleep parameters. Following 14 days of baseline monitoring, participants will collect their first bottle of the IMP (CBM or placebo) from the trial pharmacist. Participants will collect a new bottle approximately every 30 days (i.e., approximately three bottles per patient per arm of study). Participants will be asked to take the IMP one hour before sleep, and to titrate it up in 0.2 ml increases per night to a maximum dose of 1 ml (equivalent to 10mg THC). Participants who are otherwise eligible, but whose treatment regimen has changed in the previous three months, will be allowed to enrol once their treatment has been stable for 12 weeks.
Participants will be monitored regularly during the baseline period and for the first 14 days of the study , and then at weekly intervals. They will attend a clinic at approximately 28-day intervals until completion of first leg of study at 84 days.

Participants will enter a two-week washout period, followed by a second arm using the IMP that they did not receive in the first arm (CBM or Placebo), with otherwise identical research procedures.
Adherence will be monitored with urine testing at each clinic visit (every 28 days).
Intervention code [1] 325807 0
Treatment: Drugs
Comparator / control treatment
PLACEBO: a medium-chain triglyceride (MCT) carrier oil, liquid same as used for active drug.
Control group
Placebo

Outcomes
Primary outcome [1] 334362 0
Change in Insomnia Severity Index Score (ISI)
Timepoint [1] 334362 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study.
Secondary outcome [1] 420395 0
Change in Brief Pain Inventory (BPI) score
Timepoint [1] 420395 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study.
Secondary outcome [2] 424379 0
Change in Numerical rating scale (NRS) for sleep
Timepoint [2] 424379 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study.
Secondary outcome [3] 424380 0
Change in Numerical Rating Scale for pain
Timepoint [3] 424380 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study.
Secondary outcome [4] 424381 0
Total sleep time (TST) measured by accessing actigraphic device analytics (motion watch 8).
Timepoint [4] 424381 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study.
Secondary outcome [5] 424758 0
Wake after sleep onset (WASO) measured by accessing actigraphic device analytics (motion watch 8).
Timepoint [5] 424758 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study
Secondary outcome [6] 424759 0
Sleep efficiency (SE) measured by accessing actigraphic device analytics (motion watch 8).
Timepoint [6] 424759 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study
Secondary outcome [7] 424760 0
Sleep latency (SL) measured by accessing actigraphic device analytics (motion watch 8).
Timepoint [7] 424760 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study
Secondary outcome [8] 424761 0
Common Adverse effects previously reported include Dizziness (10.4%), somnolence/ fatigue(15%), nausea (5%), dry mouth (5%) and increased appetite (5%).
Serious adverse effects: Tachycardia (0.9%), heart palpitations (0.9%), psychosis/ paranoia (0.8%)and dissociation (0.2%)

Participants’ dosage and adverse effects will be monitored regularly for the first 14 days of the study (via text messages), and then at weekly intervals. They will attend a clinic at approximately 28-day intervals for further safety checks by clinical examination.
Trial participants will be asked to contact the CI with any concerns or adverse effects during the study or after its completion.
Timepoint [8] 424761 0
At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study

Eligibility
Key inclusion criteria

• Already a patient in the Bay of Plenty chronic pain services
• Chronic back pain without evidence of radiculopathy or a serious underlying disease
• Age:25-85
• Pain score >4 on Numerical Rating Scale (NRS)at baseline visit
• Insomnia Severity Index (ISI) score >14 at baseline visit
• Treatment regimen for pain or insomnia stable for three months before baseline
Minimum age
25 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current use of cannabis products
• History of significant mental illness, alcohol, or drug abuse
• Untreated cardiovascular or metabolic disorders, renal or hepatic impairment
• Other significant sleep disorders
• Pregnancy
• Use of medication which can interact with IMP
• Use of new pain or insomnia treatments 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)
Participants will be randomised by a validated and auditable REDCap module, and details of their treatment condition forwarded to the study pharmacist to facilitate dispensing. Participants will be randomised to receive either 90 days of the study drug followed by a placebo or vice versa. The CI and participants will be blinded to treatment condition until completion of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by a validated and auditable REDCap module, and details of their treatment condition forwarded to the study pharmacist to facilitate dispensing. Participants will be randomised to receive either 90 days of the study drug followed by a placebo or vice versa. The CI and participants will be blinded to treatment condition until completion of the study.
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
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
All consent and case report forms will be collected and stored using the REDCap instance hosted by the University of Auckland. Data analysis will be carried out using software such as R and Python. Actigraphic data will be analysed using the open source pyActigraphy library. The treatment effect of the study drug will be assessed by using generalised linear mixed models (GLMMs) to estimate the difference between IMP’s while accounting for within-subject correlations. The principal test will have participants included on an intention to treat basis. Per protocol analyses will also be reported. A complete statistical analysis plan will be available before recruitment

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25374 0
New Zealand
State/province [1] 25374 0
BAY OF PLENTY

Funding & Sponsors
Funding source category [1] 313570 0
University
Name [1] 313570 0
UNIVERSITY OF AUCKLAND
Country [1] 313570 0
New Zealand
Funding source category [2] 317256 0
Charities/Societies/Foundations
Name [2] 317256 0
ANZCA
Country [2] 317256 0
Australia
Primary sponsor type
University
Name
UNIVERSITY OF AUCKLAND
Address
Department of Anaesthesiology,
Building 507,
University of Auckland,
22-30 Park Avenue,
Grafton,
Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 315356 0
None
Name [1] 315356 0
Address [1] 315356 0
Country [1] 315356 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312751 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 312751 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 312751 0
New Zealand
Date submitted for ethics approval [1] 312751 0
01/09/2024
Approval date [1] 312751 0
Ethics approval number [1] 312751 0

Summary
Brief summary
our study will assess the effectiveness of a New Zealand-produced CBM Helius Full- Spectrum THC 10: CBD 10 . We plan to run a study to compare the long-term effectiveness of this CBM with that of placebo in improving sleep in patients with chronic back pain over a six-month period.

In total, 20 participants who suffer from chronic back pain and significant insomnia will be recruited. They will receive three months of CBM followed by three months of placebo, or vice versa (in random order). Neither the investigators nor the participants will be aware of which medication is which. During the study, the drug's effect on sleep and pain will be assessed using simple questionnaires and a wrist device (called an actigraph) to monitor sleep.

The results of this study will help us to understand the place of CBM in reducing insomnia in patients with chronic pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125774 0
Dr SAAD ANIS
Address 125774 0
Chronic Pain Services,
Hauora A Toi Bay Of Plenty,
829 Cameron Road,
Tauranga
3112
Country 125774 0
New Zealand
Phone 125774 0
+64 2102517180
Fax 125774 0
Email 125774 0
[email protected]
Contact person for public queries
Name 125775 0
SAAD ANIS
Address 125775 0
Chronic Pain Services,
Hauora A Toi Bay Of Plenty,
829 Cameron Road,
Tauranga
3112
Country 125775 0
New Zealand
Phone 125775 0
+64 2102517180
Fax 125775 0
Email 125775 0
[email protected]
Contact person for scientific queries
Name 125776 0
SAAD ANIS
Address 125776 0
Chronic Pain Services,
Hauora A Toi Bay Of Plenty,
829 Cameron Road,
Tauranga
3112
Country 125776 0
New Zealand
Phone 125776 0
+64 2102517180
Fax 125776 0
Email 125776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual Participant Data After Deidentification
When will data be available (start and end dates)?
Immediately Following Publication And For Five Years Post Publication
Available to whom?
Anybody Who Wishes To Access It
Available for what types of analyses?
Any Purpose
How or where can data be obtained?
Subject to approval by Pi
[email protected]


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.