Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000345684
Ethics application status
Approved
Date submitted
15/03/2023
Date registered
3/04/2023
Date last updated
26/05/2024
Date data sharing statement initially provided
3/04/2023
Date results information initially provided
26/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Double-Blind, Randomised Placebo-Controlled Feasibility Trial Assessing Oral Cannabis for The Relief of Fibromyalgia Symptoms
Scientific title
A Double-Blind, Randomised Placebo-Controlled Feasibility Trial Assessing Oral Cannabis for The Relief of Fibromyalgia Symptoms
Secondary ID [1] 308108 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CANN-RELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fibromyalgia syndrome 327805 0
chronic widespread pain 327808 0
anxiety 327809 0
depression 327810 0
sleep disturbances 327811 0
Condition category
Condition code
Alternative and Complementary Medicine 324878 324878 0 0
Herbal remedies
Musculoskeletal 324879 324879 0 0
Other muscular and skeletal disorders
Anaesthesiology 324880 324880 0 0
Pain management
Mental Health 324882 324882 0 0
Anxiety
Mental Health 324883 324883 0 0
Depression
Neurological 324884 324884 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational product (IMP) is oral medicinal cannabis oil (10mg/ml CBD:10mg/ml THC) supplied by Little Green Pharma (LGP). Excipient: Medium chain triglycerides oil (MCT), derived from sustainably sourced palm oil. The IMP can vary in colour from a transparent coloured oil to a to pale golden yellow coloured oil. The IMP is supplied in a 50mL pharmaceutical-grade amber glass bottle with a tamper-evident seal child-resistant cap. A plastic graduated 1 ml oral syringe is provided.

Due to intra-variability of participants' metabolism and response to cannabis, an initial slow increase of dose will occur for the first 4 weeks (titration) to establish the tolerated dose for that participant. After the titration period, the participants will take that dose for another 12 weeks to examine its effects on pain and other symptoms associated with fibromyalgia such as sleep, mood, and quality of life. The study duration is 16 weeks in total, plus a 4-week follow-up phone call after ceasing the medication.

During titration, participants will begin by taking 0.25ml orally 30-60 minutes before bedtime. Every two days, patients may increase the dosage by 0.25ml unless they are experiencing any undesirable side effects. If they notice any of these, they should decrease the dose by 0.25ml on the following day. The dosage should be altered only with incremental increases/decreases of 0.25 ml each time and maintained at whichever dosage proves successful once identified for the remainder of the trial. The maximum daily dosage should not exceed 3.5ml taken before bed.

Upon completion of the trial, all participants will discontinue use without tapering off and be offered one free 50ml bottle of the product utilised in the trial if desired, offering 25 days’ worth of treatment at an average of 2ml nightly.

Participants' adherence to the intervention will be monitored by measuring the remaining unused intervention oil at each follow-up meeting to calculate the number of doses missed. These will also be checked against the participant's diaries.
Intervention code [1] 324557 0
Treatment: Drugs
Intervention code [2] 324558 0
Treatment: Other
Comparator / control treatment
The control treatment will be the placebo group. The placebo will be composed of medium chain triglyceride (MCT) oil and small amounts of walnut and avocado oil to resemble the IMP in colour, texture and smell. Both the IMP and placebo will appear as a thick liquid in a dark glass 50 ml bottle with appropriate clinical trial labels on it.

A titration strategy similar to the one employed by the intervention group will be implemented for the placebo group. Participants will begin with an oral dosage of 0.25ml 30-60 minutes before bedtime and increase the dosage by 0.25ml every two days, not exceeding a daily maximum of 3.5 ml.

Participant adherence to the control treatment will be monitored by measuring the remaining unused intervention oil at each follow-up meeting to calculate the number of doses missed. These will also be checked against the participant's diaries.
Control group
Placebo

Outcomes
Primary outcome [1] 332710 0
Ratio of screened to enrolled participants: study screening/enrolment data will be collected by an audit of study screening/enrolment logs.
Timepoint [1] 332710 0
Cumulative data will be assessed at the conclusion of the study
Primary outcome [2] 332711 0
Accrual rate - the difference between projected and actual recruitment and enrolment: study enrolment data will be collected by an audit of study enrolment logs.
Timepoint [2] 332711 0
Cumulative data will be assessed at the conclusion of the study.
Primary outcome [3] 332712 0
Retention rate - percentage of participants retained at different stages throughout the trial: study enrolment/withdrawal data will be collected by an audit of study enrolment/withdrawal logs.
Timepoint [3] 332712 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [1] 414456 0
Disability associated with Fibromyalgia Syndrome (FMS) intervention compared to placebo
Timepoint [1] 414456 0
Assessed using the Fibromyalgia Impact Questionnaire Revised (FIQR) at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [2] 414457 0
Quality of life intervention compared to placebo
Timepoint [2] 414457 0
Assessed using a 36-item Short-Form Health Survey (SF-36) at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [3] 414458 0
Pain assessing intervention compared to placebo
Timepoint [3] 414458 0
Assessed via the average daily pain score (ADPS) using the 11-point Numerical Rating Scale (NRS) at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [4] 414460 0
Depression compared to intervention compared to placebo
Timepoint [4] 414460 0
Assessed using the Hospital Anxiety and Depression Scale (HADS) at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [5] 414461 0
Sleep quality intervention compared to placebo
Timepoint [5] 414461 0
Assessed using the Pittsburgh Sleep Quality Inventory (PSQI) at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [6] 414462 0
Fatigue intervention compared to placebo
Timepoint [6] 414462 0
Assessed using the Multidimensional Fatigue Inventory (MFI-20) at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [7] 414464 0
Plasma endocannabinoids - Anandamide (AEA) intervention compared to placebo
Timepoint [7] 414464 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [8] 414465 0
Plasma endocannabinoids – 2-Arachidonoylglycycerol (2-AG) intervention compared to placebo
Timepoint [8] 414465 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [9] 420126 0
Plasma endocannabinoids – Palmitoylethanolamide (PEA) intervention compared to placebo
Timepoint [9] 420126 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [10] 420127 0
Plasma endocannabinoids – Oleoylethanolamide (OEA) intervention compared to placebo
Timepoint [10] 420127 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [11] 420128 0
Plasma endocannabinoids – Stearoylethanolamide (SEA) intervention compared to placebo
Timepoint [11] 420128 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [12] 420129 0
Plasma cytokines - IL-1ß intervention compared to placebo
Timepoint [12] 420129 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation
Secondary outcome [13] 420130 0
Plasma cytokines - IL-8 intervention compared to placebo
Timepoint [13] 420130 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [14] 420131 0
Plasma cytokines - IL-6 intervention compared to placebo
Timepoint [14] 420131 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [15] 420132 0
Plasma cytokines - IL-10 intervention compared to placebo
Timepoint [15] 420132 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [16] 420133 0
Plasma cytokines - TNF-a intervention compared to placebo
Timepoint [16] 420133 0
Assessed via blood samples collected at the Enrolment (Week -4), Baseline, Week 4, Week 8, and Week 12 visits post-randomisation.
Secondary outcome [17] 420134 0
Primary outcome 4. Completion rate - the number of patients who completed the trial versus those who were randomised: study randomisation/completion data will be collected by an audit of study randomisation/completion logs.
Timepoint [17] 420134 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [18] 420135 0
Primary outcome 5. Adherence to each of the planned visits - the ratio between intended attendance and actual attendance: study visit data will be collected by an audit of study visit logs.
Timepoint [18] 420135 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [19] 420136 0
Primary outcome 6. Number of missing outcomes - the number of occasions on which study participants did not complete the study-specific questionnaires: the data will be collected by an audit of completed/incomplete study-specific questionnaire logs.
Timepoint [19] 420136 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [20] 420137 0
Primary outcome 7. Satisfaction with the outcome measurement procedures: time to complete. Time to complete outcome measurement procedures will be recorded in the study-specific End of Trial Evaluation questionnaire.
Timepoint [20] 420137 0
End of Trial Evaluation will be undertaken at Week 12 visit post-randomisation.
Secondary outcome [21] 420138 0
Primary outcome 8. Satisfaction with the outcome measurement procedures: relevance. Relevance outcome measurement procedures will be recorded in the study-specific End of Trial Evaluation questionnaire.
Timepoint [21] 420138 0
End of Trial Evaluation will be undertaken at Week 12 visit post-randomisation.
Secondary outcome [22] 420139 0
Primary outcome 9. Compliance with the treatment schedule - assessed by the number of participants taking the IMP at least 90% of the time. Compliance with the treatment schedule will be assessed by reviewing participant diaries and by measuring the remaining unused IMP at each follow up visit to calculate the number of doses missed.
Timepoint [22] 420139 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [23] 420142 0
Promary outcome 10. Safety will be assessed – safety data will be collected:
1. By an audit of the blood pathology test results, including Full Blood Count (FBC) and Electrolyte and Liver Function Tests
2. By an audit of study adverse event logs collected via direct observation by research staff on follow up phone calls and face to face visits and participant reported on participant diaries.
Adverse events previously reported for the IMP include lack of efficacy, change in taste and smell, stomach-ache, somnolence, rash, hives, headache, nausea, dizziness, hallucinations, fatigue, constipation, chills, upset stomach, diarrhea, chest pain, shaking, headache, blurred vision.
Timepoint [23] 420142 0
Safety: assessed using blood pathology tests, including Full Blood Count (FBC) and Electrolyte and Liver Function Tests, collected on Day -42, -28, 0, and Weeks 4, 8 and 12 post-randomisation and by an audit of study adverse event logs collected via direct observation by research staff on follow up phone calls and face to face visits on Day -21, -14, -7, 0 and Weeks 4, 8 and 12 post-randomisation and participant reported on participant diaries.
Secondary outcome [24] 420143 0
Primary outcome 11. Satisfaction with and tolerance of the intervention. Satisfaction with and tolerance of the intervention will be assessed via direct observation by research staff on follow up phone calls and face to face visits on Day -21, -14, -7, 0 and Weeks 4, 8 and 12 post-randomisation and participant reported on participant diaries and the End of Trial Evaluation undertaken at Week 12 visit post-randomisation.
Timepoint [24] 420143 0
Satisfaction with and tolerance of the intervention. Satisfaction with and tolerance of the intervention will be assessed via direct observation by research staff on follow-up phone calls and face-to-face visits on Day -21, -14, -7, 0 and Weeks 4, 8 and 12 post-randomisation and participant reported on participant diaries and the End of Trial Evaluation undertaken at Week 12 visit post-randomisation.
Secondary outcome [25] 420144 0
Primary outcome 12. Satisfaction with and tolerance of the titration period. Satisfaction with and tolerance of the titration period will be assessed via direct observation by research staff on follow up phone calls and face to face visits on Day -21, -14, -7, 0 and Weeks 4, 8 and 12 post-randomisation and participant reported on participant diaries and the End of Trial Evaluation undertaken at Week 12 visit post-randomisation.
Timepoint [25] 420144 0
Satisfaction with and tolerance of the titration period. Satisfaction with and tolerance of the titration period will be assessed via direct observation by research staff on follow-up phone calls and face-to-face visits on Day -21, -14, -7, 0 and Weeks 4, 8 and 12 post-randomisation and participant reported on participant diaries and the End of Trial Evaluation undertaken at Week 12 visit post-randomisation.
Secondary outcome [26] 420145 0
Primary outcome 13. Satisfaction with the trial. Satisfaction with the trial will be assessed via the End of Trial Evaluation undertaken at Week 12 visit post-randomisation.
Timepoint [26] 420145 0
Satisfaction with the trial. Satisfaction with the trial will be assessed via the End of Trial Evaluation undertaken at Week 12 visit post-randomisation.

Eligibility
Key inclusion criteria
• Age: greater than or equal to 18 years
• Able to give written informed consent
• Able to complete patient-reported outcome measures per the investigator’s discretion
• At screening, subjects must meet the 2016 American College of Rheumatology (ACR) criteria for FMS:
- Widespread pain index (WPI) greater than or equal to 7 and symptom severity score (SSS) greater than or equal to 5, or WPI 4-6 and SSS greater than or equal to 9
- Generalised pain, defined as pain in at least 4 of 5 regions, is present.
- Symptoms have been generally present for at least 3 months.
• Average daily pain score (ADPS) greater than or equal to 4 on the 11-point numeric rating scale (NRS) over the past seven days before randomisation (based on completion of at least four daily pain diaries during the 7-day baseline period before randomisation).
• Participants are willing to ensure that they or their partner use a highly effective contraception method (or combination of two less effective methods ) during the study and for 4 weeks thereafter (applicable to heterosexual female patients of childbearing potential and fertile male patients whose partners are of childbearing potential).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, hematologic illness or cardiovascular disease (e.g., severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease within 12 months before screening that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability.
• Anticipation of initiation or significant change to normal daily exercise routines or need for ongoing use of concomitant medications or non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety.
• Unable to undergo pre-study washout (30 days or less as assessed by urinary THC test) of prohibited concomitant medications/substances (including cannabis/medicinal cannabis products).
• Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or the investigator's opinion. Note: Patients answering “yes” to any of the questions about active suicidal ideation/intent/behaviours occurring within the past 12 months will be excluded (C-SSRS Suicide Ideation section – Questions 3, 4, or 5; C-SSRS Suicidal Behaviour section, any of the suicide behaviours questions). Such patients will be directed to a mental health support service.
• Current moderate severe to severe depression or anxiety disorders as assessed by the Depression Patient Health Questionnaire-9 (PHQ-9, total score of >10) and Generalized Anxiety Disorder-7 questionnaire (GAD-7, total score of >10). Still, mild to moderate depression (PHD-9 total score of 0-10) or anxiety disorders (GAD-7 total score of 0-10) are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study.
• Any diagnosis of lifetime psychotic or bipolar disorder.
• Subjects with pain due to other conditions (e.g., diabetic peripheral neuropathic pain or post-herpetic neuralgia) that, in the investigator's opinion, would confound assessment or self-evaluation of the pain associated with FMS.
• Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis, lupus) or widespread rheumatic disease other than FMS.
• Current or history of abuse or dependence on prescription medications, illicit drugs, or heavy alcohol drinking within the past year.
• Any history of a malignant neoplasm other than benign skin cancers within the past five years.
• Pregnant or breastfeeding, or intent to become pregnant during the study period or refusing to do pregnancy tests through the study.
• Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.
• Known hypersensitivity medical cannabis products. Note: Prior exposure is allowed, as long as hypersensitivity to cannabis was not observed.
• Known tree nut allergy, particularly walnut allergy.
• Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study.
• Abnormal investigative tests and laboratory values judged by the investigator to be clinically significant at screening, with particular focus on:
a. Abnormal renal function defined as calculated creatinine clearance (CrCl) < 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault equation; blood urea nitrogen> 1.5 × upper limit of normal (ULN); creatine kinase > 3.0 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 µmol/L).
b. Abnormal liver function defined as aspartate aminotransferase (AST) > 2.0 × ULN, alanine aminotransferase (ALT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analysed, and only subjects documented to have Gilbert’s syndrome may be enrolled.
• Current antipsychotic use (except for low-dose antipsychotics prescribed by a physician to treat sleep disorders).
• Current chemotherapy, radiation, immune suppressant therapy, or immunotherapy.
• Current warfarin administration.
• Vaccination of any kind in the 14 days prior to commencing IMP administration, planned vaccination during the trial period.

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)
The active and placebo bottles will appear identical from the outside and have the same weight.
A delegated unblinded Griffith University Clinical Trial Unit (CTU) staff member will receive the randomisation sequence information and receive access to the trial medications. Each drug will be in a box with either ‘1’ or ‘2’ on it. Based on the list, the unblinded CTU staff members will label each bottle with the trial number from the randomisation list supplied. The box with the ‘1’ or ‘2’ numbers will be disposed of to assist with concealment. The final bottles will not contain any group allocation information, but only be assigned based on participant ID of enrolled participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be a computer-generated random number based on block randomisation with varying block length ranging from 2 to 6. No strata will be applied. The randomisation sequence will be generated via the online platform randomizer.org.
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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed via SPSS 27.0. Analyses will be conducted on an intention-to-treat basis. An additional per-protocol analysis will be conducted. This means all participants randomised into the study that received the protocol required study product (administered at least 90% each week) exposure for at least one month will be analysed to examine the effect of compliance on the outcomes.
Basic sociodemographic and clinical data (i.e., comorbidity, medication, cannabis, or other substance use) will be collected at baseline to describe the sample and identify any confounding variables that need to be considered in the statistical analyses.
SAMPLE SIZE:
A sample size of 30 participants is considered adequate for a feasibility trial based on Browne’s flat rule of thumb for a two-armed pilot trials (Browne 1995). This feasibility trial will aim to recruit 36 participants in total (allowing 20% attrition, 18 participants per study arm).
PRIMARY OUTCOMES:
Descriptive statistics will summarise the primary outcome data as either means (absolute, relative or percentage change) with standard deviations or medians with interquartile range as appropriate for continuous data. Absolute and relative frequencies will be used for categorical variables.
SECONDARY OUTCOMES:
Clinical outcomes:
Scores of the following instruments will be compared between groups after 12 weeks at full titration, using univariate analysis (ANCOVA) or equivalent non-parametric test, depending on the distribution of data, and the effects reported as group differences with 95% confidence intervals:
1. FIQ (disability)
2. SF-36 (quality of life)
3. ADPS (pain)
4. HADS (depression)
5. PSQI (sleep)
6. MFI-20 (fatigue)
NO SIGNIFICANCE TEST will be conducted, but preliminary effect sizes will be determined to inform future studies. The responder rates will be compared using Chi2 tests. The proportion of patients reaching the predefined minimum clinically important difference (MCID) values for FIQ and ADPS scores will be identified using a Chi2 test.
Laboratory outcomes:
The following laboratory outcomes will be compared using ANCOVA and t-tests to determine if significance exists between the two groups:
1. Plasma cytokine concentrations
2. Plasma endocannabinoid concentrations.
Other statistical testing means will be assessed once the data is collected.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/06/2023
Actual
23/08/2023
Date of last participant enrolment
Anticipated
11/09/2023
Actual
29/01/2024
Date of last data collection
Anticipated
21/06/2024
Actual
Sample size
Target
36
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 23312 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 38685 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 312364 0
University
Name [1] 312364 0
Southern Cross University
Country [1] 312364 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
1 Military Road, East Lismore NSW 2480 Australia
Country
Australia
Secondary sponsor category [1] 313927 0
None
Name [1] 313927 0
Address [1] 313927 0
Country [1] 313927 0
Other collaborator category [1] 282442 0
University
Name [1] 282442 0
Griffith University Clinical Trials Unit
Address [1] 282442 0
Griffith Health Centre (G40), Griffith University, Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport QLD 4215
Country [1] 282442 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311723 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 311723 0
1 Military Rd, East Lismore NSW 2480
Ethics committee country [1] 311723 0
Australia
Date submitted for ethics approval [1] 311723 0
29/08/2022
Approval date [1] 311723 0
27/11/2022
Ethics approval number [1] 311723 0
2022/146
Ethics committee name [2] 312624 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 312624 0
Research Ethics and Integrity
Office for Research
Bray Centre (N54)
Nathan Campus,
Griffith University
170 Kessels Rd, Nathan, QLD, 4111 Australia
Ethics committee country [2] 312624 0
Australia
Date submitted for ethics approval [2] 312624 0
19/01/2023
Approval date [2] 312624 0
08/03/2023
Ethics approval number [2] 312624 0
2023/137

Summary
Brief summary
This project aims to assess the feasibility, safety, and potential efficacy of oral cannabis oil in relieving pain and other symptoms in people with fibromyalgia syndrome (FMS). Thirty-six patients (n=36, allowing 20% attrition) diagnosed with FMS will be recruited to take part in a 16-week double-blind, randomised, placebo-controlled trial. Eighteen patients will be given a product containing cannabis oil; the other 18 participants will receive a placebo oil similar in look, taste, and smell. Due to intra-variability of participants metabolism and response to cannabis, an initial slow increase of dose will occur for the first 4 weeks to establish the tolerated dose for that participant. They will then take that dose for another 12 weeks to examine its effects on pain and other symptoms associated with FMS such as sleep, mood, and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122138 0
Dr Janet Schloss
Address 122138 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
Lismore NSW 2480
Country 122138 0
Australia
Phone 122138 0
+61 0436 101 306
Fax 122138 0
Email 122138 0
janet.schloss@scu.edu.au
Contact person for public queries
Name 122139 0
Dr Janet Schloss
Address 122139 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
Lismore NSW 2480
Country 122139 0
Australia
Phone 122139 0
+61 0436 101 306
Fax 122139 0
Email 122139 0
NCNMtrials@scu.edu.au
Contact person for scientific queries
Name 122140 0
Ms Inna Kurlyandchik
Address 122140 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
Lismore NSW 2480
Country 122140 0
Australia
Phone 122140 0
+61 0492839308
Fax 122140 0
Email 122140 0
i.kurlyandchik.10@student.scu.edu.au

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.