Chronic PainPhase 1/2CYDEPSNCT04976738
A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain
A Phase 1/2 study testing Cybis™ 10:25 THC:CBD oil in people with Chronic Pain and Neck Pain, run by Cymra Life Sciences at 2 sites in Australia.
Trial summary
This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Neck Pain, Back Pain
- What is being tested?
- Cybis™ 10:25 THC:CBD oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesAustralia
- Study dates
- 20 Sep 2021to 21 Jun 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years and less than 75 years of age on the date of the Screening Visit;
- Have back and or neck pain of at least three months duration;
- Have an average back or neck pain score of between 5 and 9 on a 10-point visual analogue pain scale;
- Have failed to achieve self-reported satisfactory pain relief using over-the-counter paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs);
- 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.
- 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;
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- 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;
- 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.
- Agree to adhere to the study protocol; and
- Are willing and able to provide written informed consent.
Who cannot join
- Are pregnant or breastfeeding;
- Currently using marijuana or other medicinal cannabis products; Use of medical cannabis products > 6 months prior to Screening is acceptable;
- History of cannabis use disorder (score of 8 or higher on The Cannabis Use Disorder Identification Test - Revised (CUDIT-R);
- Current or previous allergies or allergic responses to any of the components of the study treatment (e.g., THC, CBD, MCT);
- Current or previous allergies or allergic responses to any of the components of the rescue medication (e.g. paracetamol, ibuprofen, aspirin, other NSAIDs);
- Significant cardiac disease (e.g. poorly controlled hypertension, symptomatic ischaemic heart disease, symptomatic heart failure);
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- Chronic liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper level or normal limits;
- Chronic renal impairment with eGFR <30mL/min;
- Taking sildenafil or other PDE5 inhibitors;
- 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.
- Have a major psychiatric disorder (e.g. schizophrenia, psychosis, bipolar disorder, but not anxiety or depression), by history or examination;
- Are currently using any illicit drug (including, but not limited to, amphetamines, cocaine);
- Have a history of other substance abuse disorder (as defined by DSM-5);
- Have active substance abuse disorder (alcohol, illicit drugs);
- 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;
- 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;
- Are currently participating in, or have participated (in the last 30 days) in a drug or device clinical trial;
- 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;
- COVID-19 vaccination within two (2) weeks of study assessments:
- Study assessments should not commence until two (2) weeks after a COVID-19 vaccination dose (first, second or booster dose)
- 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.
- Back and/or neck surgery within three (3) months of Screening; or
- Have history of metastatic cancer or are currently receiving treatment for cancer.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
ACRN - Australian Clinical Research Network
Maroubra, New South Wales, 2035
Holdsworth House Medical Practice
Sydney, New South Wales, 2000
About this study
Official 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
This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.
Read the detailed description
This is a non-randomised, single arm, open-label study of Cybis™ 10:25 in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.
The purpose of the study is to demonstrate the safety and tolerability of Cybis™ 10:25 in participants with moderate to severe chronic back or neck pain that is unresponsive to over-the-counter non-opioid analgesics.
Participants will undergo a screening visit, then seven clinic visits (Day 1, 2, 8, 15, 22, 29, and 35). Cybis™ 10:25 will be administered oromucosally at doses varying from 0.5 mL once daily to 1.5 mL twice daily. Total duration of dosing is 28 days.
- Conditions
- Chronic Pain, Neck Pain, Back Pain, Pain, Pain, Chronic, Pain, Back
- Being tested
- Cybis™ 10:25 THC:CBD oil
- Keywords
- medical cannabis, THC, CBD, chronic pain, neck pain, back pain, pain, dose-ranging, dose-finding
- Medical subject headings
- Chronic Pain, Neck Pain, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cybis™ 10:25 THC:CBD oilDrug
Cybis™ 10:25 containing 10 mg/mL of D9-THC and 25 mg/mL of CBD, formulated in medium chain triglycerides (MCT)
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm: Cybis™ 10:25 THC:CBD oil | Experimental | 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. Receives: Drug: Cybis™ 10:25 THC:CBD oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (and percentage) of participants with one or more adverse event
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Number (and percentage) of participants with one or more adverse event of special interest
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Number (and percentage) of participants with one or more serious adverse events
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
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.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Number (and percentage) of participants with changes in vital signs
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Number (and percentage) of participants with clinically relevant changes in physical examination
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Number (and percentage) of participants with clinically relevant changes in clinical chemistry
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Number (and percentage) of participants who drop-out
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Number (and percentage) of participants who withdraw due to adverse events
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Measured: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
Secondary outcomes (14)
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.
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The concentration at peak (Cmax) will be calculated for THC. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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.
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The time to reach peak (tmax) will be calculated for THC. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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.
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 THC. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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.
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. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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.
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The concentration at peak (Cmax) will be calculated for CBD. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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.
To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The Time to maximum concentration (tmax) will be calculated for CBD. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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.
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. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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.
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. Pharmacokinetic calculations will be conducted for each dose level individually.
Measured: 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.
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)
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).
The NPRS is an 11-point scale between 0 (no pain) and 10 (worst pain ever possible). The minimum clinically significant change in NPRS is two points. The NPRS has been validated for use in participant with low back pain.
Baseline pain levels are considered the NPRS at Day 1, irrespective of dose cohort. Change from baseline will be calculated as the pain level at the end of a dose cohort (Day 8 for 0.5 mL once daily; Day 15 for 0.5 mL bd; Day 22 for 1.0 mL bd; or Day 29 for 1.5 mL bd) minus the Day 1 value.
Measured: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
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.
The Brief Pain Inventory-Short Form is a questionnaire that assesses worst pain in the last 24 hours, least pain in the last 24 hours, average pain, and pain 'right now' along with the interference the pain causes on general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life. It will be scored according to its scoring manual [24]. Scores will be summarised at baseline, Day 8, 15, 22, 29 and 35.
Measured: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
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.
The Depression Anxiety Stress Scale (DASS) is a 21-item self-report instrument used to measure depression, anxiety and stress. The DASS will be scored according to its scoring manual. Participants will be categorised as having normal, mild, moderate, severe, or extremely severe symptoms. Lower scores indicate normal symptoms, whereas higher scores indicate severe symptoms.
Changes from baseline in DASS subscale scores will be used to investigate the dose-response relationship.
Measured: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
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.
The Medical Outcomes Sleep Scale is a 12-item scale that assesses sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. It will be scored according to its scoring manual.
The change in MOS Sleep Problems Index will be used to investigate the dose-response relationship.
Measured: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
To investigate the dose-response relationship between Cybis™ 10:25 and quality of life as measured by the change from baseline in in Self-Assessment of Treatment (SAT-II) scale.
The Self-Assessment of Treatment is a 9-item scale that measures treatment satisfaction in the previous seven days. It assesses pain, self-care activities, daily activities, physical activities, emotional well-being, sleep and social functioning, all assessed on a 5-point Likert scale. It also captures how likely the respondent would be willing to receive the study treatment again, and how study treatment compares to other treatments. The SAT-II has been validated, and is considered an acceptable endpoint for pain studies. The change in Self-Assessment of Treatment score will be used to investigate the dose-response relationship.
Measured: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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).
To investigate rescue medication use in participants prescribed Cybis™ 10:25 for chronic back and neck pain.
The proportion of patients requiring rescue medication and the number of doses of rescue medication required will be analysed descriptively. The time to first dose of rescue medication will be calculated using Kaplan-Meier methods.
Measured: Day 1, 8, 15, 22, 29 and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start20 Sep 2021
- Primary completion15 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cymra Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Chye, Study director, Cymra Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976738
- Sponsor's protocol ID
- CYM-001-21
- Acronym
- CYDEPS
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04976738
- Acronym / sponsor ID
- CYDEPS / CYM-001-21
- Conditions
- Chronic Pain, Neck Pain, Back Pain, Pain, Pain, Chronic, Pain, Back
- Keywords
- medical cannabis, THC, CBD, chronic pain, neck pain, back pain, pain, dose-ranging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cymra Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.
Detailed description
This is a non-randomised, single arm, open-label study of Cybis™ 10:25 in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.
The purpose of the study is to demonstrate the safety and tolerability of Cybis™ 10:25 in participants with moderate to severe chronic back or neck pain that is unresponsive to over-the-counter non-opioid analgesics.
Participants will undergo a screening visit, then seven clinic visits (Day 1, 2, 8, 15, 22, 29, and 35). Cybis™ 10:25 will be administered oromucosally at doses varying from 0.5 mL once daily to 1.5 mL twice daily. Total duration of dosing is 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm: Cybis™ 10:25 THC:CBD oil | Experimental | Drug: Cybis™ 10:25 THC:CBD oilCybis™ 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged over 18 years and less than 75 years of age on the date of the Screening Visit;
- Have back and or neck pain of at least three months duration;
- Have an average back or neck pain score of between 5 and 9 on a 10-point visual analogue pain scale;
- Have failed to achieve self-reported satisfactory pain relief using over-the-counter paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs);
- 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.
Key exclusion criteria (23 listed)
- Are pregnant or breastfeeding;
- Currently using marijuana or other medicinal cannabis products; Use of medical cannabis products > 6 months prior to Screening is acceptable;
- History of cannabis use disorder (score of 8 or higher on The Cannabis Use Disorder Identification Test - Revised (CUDIT-R);
- Current or previous allergies or allergic responses to any of the components of the study treatment (e.g., THC, CBD, MCT);
- Current or previous allergies or allergic responses to any of the components of the rescue medication (e.g. paracetamol, ibuprofen, aspirin, other NSAIDs);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cybis™ 10:25 THC:CBD oilCybis™ 10:25 containing 10 mg/mL of D9-THC and 25 mg/mL of CBD, formulated in medium chain triglycerides (MCT) | Drug | Treatment arm: Cybis™ 10:25 THC:CBD oil |
Primary outcome
Number (and percentage) of participants with one or more adverse event
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Number (and percentage) of participants with one or more adverse event of special interest
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Number (and percentage) of participants with one or more serious adverse events
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
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.
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Number (and percentage) of participants with changes in vital signs
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Number (and percentage) of participants with clinically relevant changes in physical examination
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Number (and percentage) of participants with clinically relevant changes in clinical chemistry
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Number (and percentage) of participants who drop-out
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
Number (and percentage) of participants who withdraw due to adverse events
Time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.
To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.
14 secondary outcomes
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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)
Time frame: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
Time frame: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
Time frame: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
Time frame: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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.
Time frame: Baseline (pre-dose), Day 1, 8, 15, 22, 29 and 35
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).
Time frame: Day 1, 8, 15, 22, 29 and 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Chye study director
Cymra Life Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cybis™ 10:25 THC:CBD oil in people with Chronic Pain and Neck Pain, run by Cymra Life Sciences at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (and percentage) of participants with one or more adverse event (time frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.