NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers

This is an interventional treatment trial for Cancer Related Pain focused on measuring Cannabis based medicine, d9-tetrahydrocannabinol, Cannabidiol, Cancer Pain, Cancer Bone Pain, Treatment, Monotherapy, Nanoparticle, Tetrahydrocannabinol Read More

Inclusion Criteria:

At Screening Phase

Participants must fulfil all of the following criteria:

• Prospective male and female participants that are:

  1. in the age range 18-65 years or
  2. 65 to 75 years without significant co-morbidities (heart, lung, liver or renal failure, myocardial infarction, cerebral vascular accident, peripheral vascular disease, chronic obstructive pulmonary disease, dementia, connective tissue disease or diabetes mellitus with end-organ damage)
• Metastatic bone pain from a cancer diagnosis is the only major cause of pain.
• Documented proof (imaging) confirming the Metastatic Bone Disease at the current site of pain and that there has no been treatment since diagnosis
• Meet International Classification of Diseases, Tenth Revision (ICD-10) codes for pain management criteria (i.e., bone cancer pain)
• During the screening period, the participant is on stable opioid pain management and pain severity (NPRS) ≤ 8 with a maximum variation of ± 1
• Pain Detect score > 18

• Participant willing and able to provide informed consent and follow study procedures

  1. including agreeing to not drive or operate heavy machinery; and
  2. females of child-bearing potential agree to use reliable contraception during the duration of the clinical trial
• Patient deemed tolerable to Oxycodone and NanaBis™ determined by medical history of allergies to cannabinoids or opioids
• Patient must not be a participant in a clinical trial or study.

Exclusion Criteria:

At Screening Phase

Participants will be excluded if they meet any of the following criteria that include:

• History of epilepsy or recurrent seizures

• Moderate to severe medical conditions such as

  1. Severe hepatic, cardiovascular, pulmonary or renal impairment or
  2. Psychiatric disorders (i.e., unstable schizophrenia, recent drug-induced psychosis, severe mood disorders), that would be assessed at the medical screen
• If participants have been diagnosed with a current substance abuse disorder
• Women who are pregnant, lactating or planning to become pregnant
• Identified concerns by the nursing / medical team relevant to the safe storage of medications (i.e., NanaBis™ or standard medical therapy)
• Participants who may not be available for follow up (i.e., planned or expected travel or other)
• Participants plan to undergo any treatment that will substantially reduce the burden of disease (and therefore bone pain) during the screening, titration or maintenance phase of the clinical trial such as radiotherapy or cytotoxic chemotherapy
• Participants who are unable to withhold all analgesia (apart from which is part of this trial) during the titration and maintenance phase of the study, including bisphosphonates, or are currently exceeding equivalence of 70mg BD Oxycodone CR. Medications such as bisphosphonates may be coordinated so they are given either side of the excluded period that covers the titration and maintenance phases
• Participants will NOT be excluded if they are being treated with maintenance pharmacotherapy to prevent progression of disease such as steroids and hormone therapy, which may be continued during the trial at a stable dose
• Participant will be excluded if they are participating in any other clinical trial or study.