A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chroni... | NCT04976738

NCT04976738

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
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.	Drug: Cybis™ 10:25 THC:CBD oil

Name	Type	Description	Arm Group Labels	Other Names
Cybis™ 10:25 THC:CBD oil	Drug	Cybis™ 10:25 containing 10 mg/mL of D9-THC and 25 mg/mL of CBD, formulated in medium chain triglycerides (MCT)	Treatment arm: Cybis™ 10:25 THC:CBD oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	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.	Safety and tolerability will be assessed throughout the trial. Up to 35 days.

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
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.

Exclusion Criteria:

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);
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:
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.
Back and/or neck surgery within three (3) months of Screening; or
Have history of metastatic cancer or are currently receiving treatment for cancer.

Facility	Status	City	State	ZIP	Country	Contacts
ACRN - Australian Clinical Research Network		Maroubra	New South Wales	2035	Australia
Holdsworth House Medical Practice

ID	Term
D059350	Chronic Pain
D019547	Neck Pain
D001416	Back Pain
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms