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Trial registered on ANZCTR


Registration number
ACTRN12622001319763
Ethics application status
Approved
Date submitted
5/10/2022
Date registered
12/10/2022
Date last updated
25/04/2024
Date data sharing statement initially provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase III study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain
Scientific title
A multi-site, parallel-arm, randomised, double blind, placebo-controlled study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain
Secondary ID [1] 308065 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 327757 0
Condition category
Condition code
Mental Health 324828 324828 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will enrol 300 participants across 4 dosing arms. Participants will receive a daily oral dose of EMD-RX5 or matching placebo for 4 weeks. Active treatment arms as below:
Arm A: 150mg EMD-RX5 CBD capsules (2x 50mg capsules in the morning, 1x 50mg capsule in the evening)
Arm B: 50mg EMD-RX5 CBD capsules (1x 50mg capsules in the morning)
Intervention code [1] 324513 0
Treatment: Drugs
Comparator / control treatment
Gelatine placebo capsules are used as the comparator treatment for this study. Placebo capsules do not contain CBD, but are otherwise identical to the investigational medicine. Placebo arms as below:
Arm C: 150mg Placebo capsules (2x capsules in the morning, 1x capsule in the evening)
Arm D: 50mg Placebo capsules (1x capsules in the morning)
Control group
Placebo

Outcomes
Primary outcome [1] 332643 0
To determine the effect of EMD-RX5 treatment on symptoms of psychological distress in participants with chronic pain based on change in self-reported Depression, Anxiety and Distress Scale-21 (DASS-21) anxiety symptom score.
Timepoint [1] 332643 0
DASS-21 anxiety symptom assessment completed at baseline and Week 4 post intervention commencement
Secondary outcome [1] 414209 0
To determine the effect of EMD-RX5 on symptoms of psychological distress in participants with chronic pain based on change in self-reported DASS-21 anxiety symptom score
Timepoint [1] 414209 0
DASS-21 anxiety symptom assessment completed at baseline, Week 1 and Week 2 post intervention commencement
Secondary outcome [2] 414210 0
To determine the effect of EMD-RX5 on symptoms of psychological distress in participants with chronic pain based on change in self-reported DASS-21 stress symptom score
Timepoint [2] 414210 0
DASS-21 stress symptom assessment completed at Baseline, Week 1, 2 and 4 post intervention commencement
Secondary outcome [3] 414211 0
To determine the effect of EMD-RX5 on symptoms of psychological distress in participants with chronic pain based on change in self-reported DASS-21 depression symptom score
Timepoint [3] 414211 0
DASS-21 depression symptom assessment completed at Baseline, Week 1, 2 and 4 post intervention commencement
Secondary outcome [4] 414212 0
To determine the safety and tolerability of low dose CBD (EMD-RX5) in participants with chronic pain and symptoms of psychological distress.

Examples of possible adverse events are: sleepiness, allergic reaction, injury to cells in the liver. Clinical assessments will include: heart rate assessed by digital heart rate monitor, temperature assessed using infrared thermometer, blood pressure assessed by digital sphygmomanometer. Laboratory measures (blood tests) will also be used to assess safety, including liver function tests and full blood count tests (red blood cells, white blood cells and platelet cells).
Timepoint [4] 414212 0
Adverse events will be assessed and recorded at the Week 4 visit and Week 5 phone follow-up (post intervention commencement) as well as at any point a patient notifies the study site.
Secondary outcome [5] 414213 0
To determine the effect of EMD-RX5 treatment on perception of sleep in participants with chronic pain and symptoms of psychological distress.
Timepoint [5] 414213 0
Insomnia Severity Index (ISI) questionnaire completed at baseline, Week 2 and 4 post intervention commencement
Secondary outcome [6] 414214 0
To determine the effect of EMD-RX5 treatment on pain interference in participants with chronic pain and symptoms of psychological distress.
Timepoint [6] 414214 0
Brief Pain Inventory - Short Form (BPI-SF) pain interference assessment completed at baseline, Weeks 1, 2 and 4 post intervention commencement
Secondary outcome [7] 414215 0
To determine the effect of EMD-RX5 treatment on perceived quality of life in participants with chronic pain and symptoms of psychological distress.
Timepoint [7] 414215 0
Short Form 36 (SF-36) quality of life assessment completed at baseline and Week 4 post intervention commencement

Eligibility
Key inclusion criteria
- Chronic pain (defined as pain that has persisted for at least 3 months prior to date of consent)
- Self-reported at least mild psychological distress symptoms as measured by a baseline DASS-21 anxiety symptom score 8 or more
- If taking pain medications at the time of screening dose must be stable for at least one month prior to study screening
- Women of childbearing potential and men with sexual partners of childbearing potential must confirm the use of at least one acceptable form of contraception to be used throughout study participation.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current diagnosis of mental health disorder as defined by DSM-5
- Currently taking or has taken any psychotropic medications for treatment of mental health illness for one month prior to screening
- Current suicidality or self-harm ideation
- Pregnant females
- History of drug or alcohol abuse within 6 months of screening as per investigator judgement or a positive urine drug screen for THC
- Currently taking or has taken any cannabinoid products within 30 days of trial treatment.

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)
Central randomisation by computer
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
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is expected that 300 participants will be recruited (100 participants for each active arm (EMD-RX5 50mg and EMD-RX5 150mg) and 50 participants for each control arm (placebo 50mg and placebo 150mg) allowing for a 10% dropout rate. Assuming a placebo response of -1 and an active response of -3 (2-point treatment difference with a within group standard deviation of 7) and allowing for a 10% dropout rate, approximately 100 participants per active arm and 50 participants per control arm (Total 300 participants) will achieve 80% power to detect a 2-point difference between the DASS-21 anxiety symptom means with a 5% significance level (analysis of covariance).

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
23/01/2023
Actual
27/01/2023
Date of last participant enrolment
Anticipated
30/06/2023
Actual
28/07/2023
Date of last data collection
Anticipated
4/08/2023
Actual
Sample size
Target
300
Accrual to date
160
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 312322 0
Commercial sector/Industry
Name [1] 312322 0
Emyria Ltd
Country [1] 312322 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Emyria Ltd
Address
D2 661 Newcastle Street, Leederville WA 6007
Country
Australia
Secondary sponsor category [1] 313875 0
None
Name [1] 313875 0
Address [1] 313875 0
Country [1] 313875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311689 0
Bellberry Ltd
Ethics committee address [1] 311689 0
123 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 311689 0
Australia
Date submitted for ethics approval [1] 311689 0
07/07/2022
Approval date [1] 311689 0
15/08/2022
Ethics approval number [1] 311689 0

Summary
Brief summary
Symptoms of psychological distress, also described as acute stress, anxiety or nervous tension are particularly common in patients suffering chronic pain. EMD-RX5 is a cannabidiol (CBD) capsule. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. The purpose of this study is to determine whether EMD-RX5 improves symptoms of psychological distress in patients experiencing chronic pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122006 0
Dr Michael Benson
Address 122006 0
Captain Stirling Medical Centre, 92 Stirling Hwy, Nedlands WA 6009
Country 122006 0
Australia
Phone 122006 0
+61 08 9386 1858
Fax 122006 0
Email 122006 0
[email protected]
Contact person for public queries
Name 122007 0
Naomi Brook
Address 122007 0
Emyria Ltd
D2 661 Newcastle Street
Leederville, Western Australia 6007
Country 122007 0
Australia
Phone 122007 0
+610865592800
Fax 122007 0
Email 122007 0
[email protected]
Contact person for scientific queries
Name 122008 0
Naomi Brook
Address 122008 0
Emyria Ltd
D2 661 Newcastle Street
Leederville, Western Australia 6007
Country 122008 0
Australia
Phone 122008 0
+610865592800
Fax 122008 0
Email 122008 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
Intellectual property


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.