CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients

NCT ID: NCT05288010

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-06-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Group

Patients of the clinic receiving cannabis treatment for non cancer chronic pain, who have been invited to join the study and have agreed and consented to join study.

Group Type: OTHER

Cannabis

Intervention Type: COMBINATION_PRODUCT

The provision of whole flower cannabis via an inhalation device in addition to standard of care chronic pain treatment.

Interventions

Cannabis

The provision of whole flower cannabis via an inhalation device in addition to standard of care chronic pain treatment.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harley Street (CPC) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaw Sorooshian, MB ChB

Role: PRINCIPAL_INVESTIGATOR

LVL Health

Locations

LVL Health

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRAS 304548

Identifier Type: -

Identifier Source: org_study_id