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

Unknown statusPhase 3NCT05288010
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
CANPAIN Feasibility Study: Evaluating the Feasibility of Subsequently Undertaking a Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients
Conditions
Interventions
  • Combination product: Cannabis
Sponsor
Harley Street (CPC) Limited
Start date
2022-03-15
Primary completion
2022-06-15
Sex
All
Age range
from 18 Years to 85 Years
Results posted
No results posted in this snapshot
Countries
United Kingdom
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05288010