Clinical trial NCT05288010: CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients
Official title: CANPAIN Feasibility Study: Evaluating the Feasibility of Subsequently Undertaking a Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Cannabis
Whole Flower Cannabis
Lead sponsor: Harley Street (CPC) Limited
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Treatment with cannabis via an inhalation device in addition to standard of care chronic pain treatment.
Primary purpose: TREATMENT

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 private clinic. CANPAIN is a pragmatic non-randomised, non-blinded real-world trial of the safety, tolerability and effectiveness of a cannabis based medicinal product (CBMP) for the treatment of chronic non-cancer pain compared against matched controls receiving standard of care pain management. CANPAIN will run for 3 years with a minimal planned sample size of 5000 participants per group who have completed at least 12 months of treatment. CANPAIN will be an MHRA and REC approved study. (See Appendix 1 of the Feasibility Study for the full draft protocol of the CANPAIN Study)

Prior to commencing the CANPAIN study, the sponsor proposes to conduct a feasibility study. This study will aid in establishing likely rates of patient recruitment, duration of participant enrolment in the study, the demographic and geographic spread of patients, patient acceptability of data collection and identify any issues with technological and drug delivery logistics.

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 clinical information they are required to provide, and the informed consent required for treatment, will all follow the clinical protocol. The sponsor wishes to assess the feasibility of conducting the study within the private clinic to aid a future submission to Oxford A REC of the CANPAIN study.

The feasibility study will be conducted over a 3-month period with a minimum target recruitment number of 100 patients. Feasibility will be assessed through 3 distinct domains: Recruitment and patient experience, medication logistics and data management.

Patient experiences (part of domain 3) will be captured using comment forms, requesting feedback on ease of onboarding, ease of answering questionnaires, evidence of questionnaire fatigue and their satisfaction of service.

Eligibility criteria: Inclusion Criteria:

1. A consented patient at the clinic;
2. Male or female 18-85 years old;
3. Diagnosed with chronic non-cancer pain;
4. 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";
5. Despite being on or having received standard of care and has still pain (\>3 on the Pain NRS); and
6. Signed and dated consent form from the patient.

Exclusion Criteria:

1. Pregnant or lactating females or females who are planning a pregnancy during the study;
2. Positive pregnancy test at time of joining the clinic;
3. Major organ failure, renal, lung or liver failure;
4. Participants having active liver disease or unexplained persistent elevation of serum transaminases \> 3 times the upper limit of normal;
5. Participants with a creatinine clearance \< 60mL/min;
6. History of cardiac or respiratory failure;
7. History of recent myocardial infarction or poorly controlled ischaemic heart disease;
8. Severe respiratory disease (e.g., GOLD 3 for COPD or asthmatics requiring high doses of oral corticosteroids);
9. History or presence of alcohol or substance abuse, including analgesics used as standard of care;
10. Participation in a clinical trial of an investigational medicinal product;
11. 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;
12. Known hypersensitivity to cannabis or allergy to cannabis or CBMP; and
13. Currently taking cannabis and does not agree to a 3 week wash out period.

Primary outcomes:
measure: Recruitment Experience
timeFrame: 3 months
measure: Duration of Time in Study
timeFrame: 3 months
measure: Questionnaire Compliance
timeFrame: 3 months
measure: Safety Questionnaire Results
timeFrame: 3 months
measure: Medication Logistics
timeFrame: 3 months
measure: Device Experience
timeFrame: 3 months
measure: Onboarding Experience
timeFrame: 3 months
measure: Questionnaire Logistics and Satisfaction
timeFrame: 3 months
measure: Questionnaire Fatigue
timeFrame: 3 months
measure: Patient Satisfaction with Service
timeFrame: 3 months
Secondary outcomes:
measure: Demographic
timeFrame: 3 months
measure: Conversion to Registration
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: LVL Health
Study officials:
affiliation: LVL Health
name: Shaw Sorooshian, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: