A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain

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.