Chronic PainPhase 3CANPAINNCT05288010
CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients
A Phase 3 study testing Cannabis in people with Chronic Pain, run by Harley Street (CPC) Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2022to 30 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CANPAIN Feasibility Study: Evaluating the Feasibility of Subsequently Undertaking a Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients
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.
Read the 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
- Being tested
- Cannabis
- Keywords
- Cannabis, Whole Flower Cannabis
- Medical subject headings
- Chronic Pain, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisCombination product
The provision of whole flower cannabis via an inhalation device in addition to standard of care chronic pain treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Other | 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. Receives: Combination Product: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Experience
Assess rate of recruitment to the clinic. Measure time taken to recruit the first 100 patients from time of first patient in study until end of study. This will be measured using an electronic patient record which will record the date each patient entered and left the study.
Measured: 3 months
Duration of Time in Study
Assess the number/proportion of patients that cease treatment at the Clinic. Measure the average time all patients remained in the study. This will be measured using an electronic patient record which will record the date each patient entered and left the study.
Measured: 3 months
Questionnaire Compliance
Assess the number of patients that complete all questionnaires required. Measure the percentage of patients that completed all questionnaires required as part of the study.
Measured: 3 months
Safety Questionnaire Results
Assess the number of patients that experience safety issues. Report the number of patients that recorded a score of 5 or more on the NRS tolerability questionnaire, in any of the safety questions.
Measured: 3 months
Medication Logistics
Assess the timeliness and efficiency of CBMP delivery to the patient. Record average time taken for medication to reach patients after prescription has been completed using the shipping data from the pharmacy and the receipt date by the patient from the courier.
Measured: 3 months
Device Experience
Assess the presence of issues with the usability of the inhalation device. Record number of patients that had issues with using the device from the comments questionnaire and from emails and phone calls to the study site.
Measured: 3 months
Onboarding Experience
Ease of onboarding. Report from comments questionnaire and email and phone interactions with study site number of patients that had difficulties with registering with the clinic and entering into the study.
Measured: 3 months
Questionnaire Logistics and Satisfaction
Ease of answering questionnaires. Record the number of patients that had problems with accessing or filling in the questionnaires from comments questionnaire and email and phone interactions with the study site.
Measured: 3 months
Questionnaire Fatigue
Evidence of questionnaire fatigue. Report on the number of people that did not complete all questionnaires or did not complete them correctly or who complained about the number of questionnaires and questions in each questionnaire from the comments form and emails and phone calls to study site.
Measured: 3 months
Patient Satisfaction with Service
Patients are required to fill out a Feedback Questionnaire which has a number of questions within it regards the service provided. Patients are required to rate the answers to these questions as Excellent, Good, Fair or Poor. The percentage of patients recording Excellent, Good, Fair and Poor will be calculated and tabulated and reported on.
Measured: 3 months
Secondary outcomes (2)
Demographic
Assess the socio-economic status and geographic origin of patients. Report on the number of patients by postcode to get an impression of socio-economic and demographic spread of the patients.
Measured: 3 months
Conversion to Registration
Assess the number of enquiries to webpage and completion of registration forms. Report on the number of visits to the study site website and what percentage of these lead to a registration form being completed by the patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion15 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment with cannabis via an inhalation device in addition to standard of care chronic pain treatment.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harley Street (CPC) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaw Sorooshian, MB ChB, Principal investigator, LVL Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288010
- Sponsor's protocol ID
- IRAS 304548
- Acronym
- CANPAIN
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summarised data will be made available via this site and peer review publications
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CANPAIN Feasibility Study: Evaluating the Feasibility of Subsequently Undertaking a Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT05288010
- Acronym / sponsor ID
- CANPAIN / IRAS 304548
- Conditions
- Chronic Pain
- Keywords
- Cannabis, Whole Flower Cannabis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Harley Street (CPC) LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with cannabis via an inhalation device in addition to standard of care chronic pain treatment.
| Arm | Type | Receives |
|---|---|---|
| Active Group | Other | Combination Product: CannabisPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisThe provision of whole flower cannabis via an inhalation device in addition to standard of care chronic pain treatment. | Combination product | Active Group |
Primary outcome
Recruitment Experience
Time frame: 3 months
Assess rate of recruitment to the clinic. Measure time taken to recruit the first 100 patients from time of first patient in study until end of study. This will be measured using an electronic patient record which will record the date each patient entered and left the study.
Duration of Time in Study
Time frame: 3 months
Assess the number/proportion of patients that cease treatment at the Clinic. Measure the average time all patients remained in the study. This will be measured using an electronic patient record which will record the date each patient entered and left the study.
Questionnaire Compliance
Time frame: 3 months
Assess the number of patients that complete all questionnaires required. Measure the percentage of patients that completed all questionnaires required as part of the study.
Safety Questionnaire Results
Time frame: 3 months
Assess the number of patients that experience safety issues. Report the number of patients that recorded a score of 5 or more on the NRS tolerability questionnaire, in any of the safety questions.
Medication Logistics
Time frame: 3 months
Assess the timeliness and efficiency of CBMP delivery to the patient. Record average time taken for medication to reach patients after prescription has been completed using the shipping data from the pharmacy and the receipt date by the patient from the courier.
Device Experience
Time frame: 3 months
Assess the presence of issues with the usability of the inhalation device. Record number of patients that had issues with using the device from the comments questionnaire and from emails and phone calls to the study site.
Onboarding Experience
Time frame: 3 months
Ease of onboarding. Report from comments questionnaire and email and phone interactions with study site number of patients that had difficulties with registering with the clinic and entering into the study.
Questionnaire Logistics and Satisfaction
Time frame: 3 months
Ease of answering questionnaires. Record the number of patients that had problems with accessing or filling in the questionnaires from comments questionnaire and email and phone interactions with the study site.
Questionnaire Fatigue
Time frame: 3 months
Evidence of questionnaire fatigue. Report on the number of people that did not complete all questionnaires or did not complete them correctly or who complained about the number of questionnaires and questions in each questionnaire from the comments form and emails and phone calls to study site.
Patient Satisfaction with Service
Time frame: 3 months
Patients are required to fill out a Feedback Questionnaire which has a number of questions within it regards the service provided. Patients are required to rate the answers to these questions as Excellent, Good, Fair or Poor. The percentage of patients recording Excellent, Good, Fair and Poor will be calculated and tabulated and reported on.
2 secondary outcomes
Demographic
Time frame: 3 months
Conversion to Registration
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No. Summarised data will be made available via this site and peer review publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaw Sorooshian, MB ChB principal investigator
LVL Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabis in people with Chronic Pain, run by Harley Street (CPC) Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Experience (time frame: 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.