Status:
UNKNOWN
CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients
Lead Sponsor:
Harley Street (CPC) Limited
Conditions:
Chronic Pain
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The CANPAIN study has been devised to evaluate the efficacy and safety of a defined cannabis based medicinal product (CBMP) delivered by inhalation to patients with non cancer chronic pain attending a...
Detailed Description
The feasibility study will be based within a private clinic setting and will only involve existing patients of the clinic. The treatment regime, tests that the patients are required to take, the clini...
Eligibility Criteria
Inclusion
- A consented patient at the clinic;
- Male or female 18-85 years old;
- Diagnosed with chronic non-cancer pain;
- Is currently receiving standard of care but still has pain, has completed standard of care pain treatment, does not want standard of care treatment, or standard of care is contraindicated. An inadequate response is defined as the subject receiving standard analgesic agents and still has pain, has unpleasant side effects or wishes to reduce their intake of standard of care analgesic agents, e.g. a subject receiving opioids who wishes to dose reduce in light of the "opioid crisis";
- Despite being on or having received standard of care and has still pain (\>3 on the Pain NRS); and
- Signed and dated consent form from the patient.
Exclusion
- Pregnant or lactating females or females who are planning a pregnancy during the study;
- Positive pregnancy test at time of joining the clinic;
- Major organ failure, renal, lung or liver failure;
- Participants having active liver disease or unexplained persistent elevation of serum transaminases \> 3 times the upper limit of normal;
- Participants with a creatinine clearance \< 60mL/min;
- History of cardiac or respiratory failure;
- History of recent myocardial infarction or poorly controlled ischaemic heart disease;
- Severe respiratory disease (e.g., GOLD 3 for COPD or asthmatics requiring high doses of oral corticosteroids);
- History or presence of alcohol or substance abuse, including analgesics used as standard of care;
- Participation in a clinical trial of an investigational medicinal product;
- With any known or suspected history or family history of schizophrenia, or other psychotic illness; history of severe personality disorder or other significant psychiatric disorder disorders other than depression associated with their underlying condition;
- Known hypersensitivity to cannabis or allergy to cannabis or CBMP; and
- Currently taking cannabis and does not agree to a 3 week wash out period.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05288010
Start Date
March 15 2022
End Date
June 30 2022
Last Update
March 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LVL Health
London, United Kingdom, W1G 9HH