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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04976738




Registration number
NCT04976738
Ethics application status
Date submitted
30/06/2021
Date registered
26/07/2021

Titles & IDs
Public title
A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain
Scientific title
A Dose-ranging Study to Examine the Pharmacokinetics, Safety, Tolerability and Efficacy of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain
Secondary ID [1] 0 0
CYM-001-21
Universal Trial Number (UTN)
Trial acronym
CYDEPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Neck Pain 0 0
Back Pain 0 0
Pain 0 0
Pain, Chronic 0 0
Pain, Back 0 0
Pain, Neck 0 0
CBD 0 0
THC 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cybis™ 10:25 THC:CBD oil

Experimental: Treatment arm: Cybis™ 10:25 THC:CBD oil - Cybis™ 10:25 THC:CBD oil administered oromucosally at doses varying from 0.5 mL once daily to 1.5 mL twice daily. Total duration of dosing is 28 days.


Treatment: Drugs: Cybis™ 10:25 THC:CBD oil
Cybis™ 10:25 containing 10 mg/mL of D9-THC and 25 mg/mL of CBD, formulated in medium chain triglycerides (MCT)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number (and percentage) of participants with one or more adverse event
Timepoint [1] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [2] 0 0
Number (and percentage) of participants with one or more adverse event of special interest
Timepoint [2] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [3] 0 0
Number (and percentage) of participants with one or more serious adverse events
Timepoint [3] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [4] 0 0
Adverse events, adverse events of special interest, serious adverse events will be summarised descriptively with the number of participants experiencing the event and the percentages of participants experiencing the event.
Timepoint [4] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [5] 0 0
Number (and percentage) of participants with changes in vital signs
Timepoint [5] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [6] 0 0
Number (and percentage) of participants with clinically relevant changes in physical examination
Timepoint [6] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [7] 0 0
Number (and percentage) of participants with clinically relevant changes in clinical chemistry
Timepoint [7] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [8] 0 0
Number (and percentage) of participants who drop-out
Timepoint [8] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Primary outcome [9] 0 0
Number (and percentage) of participants who withdraw due to adverse events
Timepoint [9] 0 0
Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Secondary outcome [1] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Peak plasma concentration (Cmax) of THC in plasma.
Timepoint [1] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [2] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Time to maximum concentration (tmax) of THC in plasma.
Timepoint [2] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [3] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Area under the concentration/time curve (AUC) will be calculated for THC.
Timepoint [3] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [4] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The elimination half-life (t1/2) will be calculated for THC.
Timepoint [4] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [5] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Peak plasma concentration (Cmax) of CBD in plasma.
Timepoint [5] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [6] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Time to maximum concentration (tmax) of CBD in plasma.
Timepoint [6] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [7] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The area under the concentration/time curve (AUC) will be calculated for CBD.
Timepoint [7] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [8] 0 0
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The elimination half-life (t1/2) will be calculated for CBD.
Timepoint [8] 0 0
Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.
Secondary outcome [9] 0 0
To investigate the dose-response relationship between Cybis™ 10:25 and pain response, as measured by the change from baseline in Numerical Pain Rating Scale (NPRS)
Timepoint [9] 0 0
Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
Secondary outcome [10] 0 0
To investigate the dose-response relationship between Cybis™ 10:25 and pain response, as measured by the change from baseline in Brief Pain Inventory - Short Form.
Timepoint [10] 0 0
Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
Secondary outcome [11] 0 0
To investigate the dose-response relationship between Cybis™ 10:25 and quality of life as measured by the change from baseline in Depression Anxiety Stress Scale.
Timepoint [11] 0 0
Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
Secondary outcome [12] 0 0
To investigate the dose-response relationship between Cybis™ 10:25 and quality of life as measured by the change from baseline in Medical Outcomes Sleep Survey.
Timepoint [12] 0 0
Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
Secondary outcome [13] 0 0
To investigate the dose-response relationship between Cybis™ 10:25 and quality of life as measured by the change from baseline in Self-Assessment of Treatment (SAT-II) scale.
Timepoint [13] 0 0
Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
Secondary outcome [14] 0 0
To investigate rescue medication use in participants prescribed Cybis™ 10:25 (proportion of patients requiring rescue medication, the number of doses of rescue medication required, the time to rescue medication).
Timepoint [14] 0 0
Day 1, 8, 15, 22, 29 and 35

Eligibility
Key inclusion criteria
1. Aged over 18 years and less than 75 years of age on the date of the Screening Visit;
2. Have back and or neck pain of at least three months duration;
3. Have an average back or neck pain score of between 5 and 9 on a 10-point visual analogue pain scale;
4. Have failed to achieve self-reported satisfactory pain relief using over-the-counter paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs);
5. Are willing to cease all current pain medications 14 days prior to commencing Cybis™ 10:25, and for the duration of the study (except as allowed under rescue medication); Note: Pain medication may include opioids (including but not limited to paracetamol+codeine combinations, codeine, tramadol, tapentadol, buprenorphine), NSAIDs and other co-analgesic medications (such as anti-epileptics, antidepressants, clonidine) and/or any other pain medications.
6. Agree to cease any dietary or herbal supplements (e.g. St John's Wort) fourteen days prior to commencing Cybis™ 10:25, and for the duration of the study;
7. Are willing to cease driving a car or operating heavy machinery from the day of first dosing to seven days after administration of the last dose of Cybis™ 10:25;
8. Agree to use contraception throughout the study, and for one month after the last dose of Cybis™ 10:25 is administered (if reproductive age female) or three months after the last dose of Cybis™ 10:25 is administered (if male); Note: women of childbearing potential must have a negative serum or urine pregnancy test prior to entry into the study. For women, adequate contraception is a double barrier method for the duration of the study and for 30 days post the last study dose. For men, barrier contraception is required for the duration of the study and for 3 months after the last study dose.
9. Agree to adhere to the study protocol; and
10. Are willing and able to provide written informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Are pregnant or breastfeeding;
2. Currently using marijuana or other medicinal cannabis products; Use of medical cannabis products > 6 months prior to Screening is acceptable;
3. History of cannabis use disorder (score of 8 or higher on The Cannabis Use Disorder Identification Test - Revised (CUDIT-R);
4. Current or previous allergies or allergic responses to any of the components of the study treatment (e.g., THC, CBD, MCT);
5. Current or previous allergies or allergic responses to any of the components of the rescue medication (e.g. paracetamol, ibuprofen, aspirin, other NSAIDs);
6. Significant cardiac disease (e.g. poorly controlled hypertension, symptomatic ischaemic heart disease, symptomatic heart failure);
7. Chronic liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper level or normal limits;
8. Chronic renal impairment with eGFR <30mL/min;
9. Taking sildenafil or other PDE5 inhibitors;
10. Being treated with known inducers/inhibitors of CYP3A4, in particular clarithromycin, rifampicin, azole antifungals, antiretroviral agents, anticonvulsants (phenytoin, carbamazepine), SSRI within 30 days of study commencement; Use of such enzyme-altering agents is prohibited throughout the study.
11. Have a major psychiatric disorder (e.g. schizophrenia, psychosis, bipolar disorder, but not anxiety or depression), by history or examination;
12. Are currently using any illicit drug (including, but not limited to, amphetamines, cocaine);
13. Have a history of other substance abuse disorder (as defined by DSM-5);
14. Have active substance abuse disorder (alcohol, illicit drugs);
15. Other clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, or vital signs, which in the opinion of the Investigator, may put the participant at risk of adverse events;
16. Other chronic disease (other than chronic pain) that in the opinion of the Investigator may impact the safety, efficacy and/or pharmacokinetics of the study drug;
17. Are currently participating in, or have participated (in the last 30 days) in a drug or device clinical trial;
18. Currently using opioids (including but not limited to paracetamol+codeine combinations, codeine, tramadol, tapentadol, buprenorphine) and not willing to cease opioids for the duration of the study;
19. COVID-19 vaccination within two (2) weeks of study assessments:

1. Study assessments should not commence until two (2) weeks after a COVID-19 vaccination dose (first, second or booster dose)
2. Subsequent COVID-19 vaccination doses (first, second or booster dose) should not be administered until 7 days after Day 35 study assessments have been completed.
20. Back and/or neck surgery within three (3) months of Screening; or
21. Have history of metastatic cancer or are currently receiving treatment for cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/06/2022
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ACRN - Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cymra Life Sciences
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Richard Chye
Address 0 0
Cymra Life Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04976738