Chronic PainNCT05351905
Improving Pain Disability With the Use of Oral Cannabinoids
A study testing CBD oil ( MPL-001) and CDB+THC oil (MPL-005) in people with Chronic Pain and Opioid Use, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use, Cannabis
- What is being tested?
- CBD oil ( MPL-001) and CDB+THC oil (MPL-005)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2022to 12 Jan 2026
- Phase
- Interventional
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 25 years
- Able to understand and read English
- Experiencing chronic, non-palliative pain
Who cannot join
- Use of nabilone, nabiximols or cannabis in the 30 days preceding study recruitment
- Known allergy to cannabis or any cannabinoid
- Serious ongoing medical issues (i.e., lung, liver, kidney or heart disease) that in the opinion of the Investigator would compromise the safety of the patient
- Current uncontrolled serious mental disorders such as schizophrenia, or psychosis
- Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of child bearing potential during pretreatment evaluation)
- Men and women planning to start a family in the next 12 weeks
Show all 9Show fewer
- Has declared a current alcohol or substance use disorder (excluding opioid use disorder)
- Currently using Methadone or Buprenorphine
- Patients who are naïve to pain treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Pilot, Randomized Controlled Trial of Oral Cannabinoids for Improving Pain Disability in Patients With Chronic Pain
The investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. The results of this pilot study will help the study team design a larger randomized controlled trial.
Read the detailed description
Chronic pain is defined as pain lasting longer than three months, affects ~20% of Canadian adults. In addition to having a significant negative impact at the individual patient level (i.e., decreased quality of life and functioning), chronic pain is also a main cause of disability and health care use. Opioids are frequently prescribed to manage chronic pain despite limited data on their long term usefulness and has become one of the major contributors to the current opioid crisis in Canada. Chronic pain can potentially be treated with medical cannabis as an adjunct or alternative to opioids due to their similar behavioral, anatomical and biochemical mechanisms. Cannabinoids also potentially prevent the development of tolerance to opioids when co-administered.
Cannabinoids have demonstrated the ability to reduce pain as well as opioid-sparing effects in pre-clinical and clinical studies however further research is needed to identify the optimal make-up, ratio, and dosage of cannabinoids to minimize harms and maximize benefits. Furthermore, studies conducted to date have methodological problems such as short follow-up windows (hours or days) that limit conclusions. The investigators therefore propose a randomized, placebo-controlled trial of oral cannabinoids [CBD (cannabidiol) alone or in combination with THC (delta-9-tetrahydrocannabinol)] for reducing pain disability and opioid use for pain management in chronic pain. However, there are a number of feasibility issues that should be addressed prior to launching a full-scale trial in this area. Some issues have been identified in the literature (e.g., success of blinding) while others are related to the changing socio-medico-legal landscape surrounding cannabis use in Canada.
The purpose of this pilot study is to test the study plan, patient recruitment and compliance with the study procedures. Results of this study may be used as a guide for larger studies and will help us determine if medical cannabis can reduce daily opioid doses and/or decrease pain interference (disability) in chronic pain patients.
This study will aim to recruit 51 patients from the Toronto General Hospital Transitional Pain Service.
Study Procedure: After obtaining the Informed consent, patients will be randomized into one of the three study groups. Patients will either receive CBD oil, CBD+THC oil or placebo orally for 12 weeks. Starting dose will be 1 ml per day. The dose of study drug will be adjusted based on patients' reported efficacy and adverse effects. After starting the study drug, patients will have scheduled study visits either remotely or in-person at 4, 8, and 12 weeks plus a follow up calls or virtual clinic visit(OTN) at 2 and 6 weeks. At every study visit, patients will be asked to complete the questionnaires that will assess their pain level and how it affects their quality of life, opioid use, and side effects if they are experiencing. The investigators will also collect information on: demographic and baseline characteristics (e.g., sex, age, height, weight, and body mass index) and medical history (including prior and concomitant medications) via patient interview or from inspection of medical records. Additionally, symptoms of depression and anxiety will be measured with the validated screening tools at baseline and 12 weeks post-treatment.
- Conditions
- Chronic Pain, Opioid Use, Cannabis
- Being tested
- CBD oil ( MPL-001), CDB+THC oil (MPL-005), Placebo oil
- 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.
CBD oil ( MPL-001)Drug
Also called CBD concentrate
MPL-001: which is a 25:1 Cannabidiol (CBD): ∆9-tetrahydrocannabidiol (THC) oral formulation with a concentration of 50 mg/ml of CBD and 2 mg/ml of THC. The starting dose will be 1 mL per day (50 mg CBD) orally and gradually titrated to a maximum dose of 6 mL (300 mg CBD) per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial.
CDB+THC oil (MPL-005)Drug
Also called CBD concentrate
MPL-005: which is a 5:1 Cannabidiol (CBD):∆9-tetrahydrocannabidiol (THC) oral formulation with a concentration of 25 mg/ml of CBD and 5 mg/ml of THC. The starting dose will be 1 mL per day (25 mg CBD + 5 mg THC) orally and gradually titrated to a maximum dose of 6 mL (150 mg CBD + 30 mg THC) per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial.
Placebo oilDrug
Also called Matching placebo
The starting dose will be 1 mL per day (contains no API) orally and gradually titrated to a maximum dose of 6 mL per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial.
| Study group | Role | What they receive |
|---|---|---|
| CBD oil | Experimental | Participants will receive CBD (cannabidiol) oil for a total duration of 12 weeks. Receives: Drug: CBD oil ( MPL-001) |
| CBD+THC oil | Experimental | Participants will receive CBD (cannabidiol) oil in combination with THC (delta-9-tetrahydrocannabinol) for a total duration of 12 weeks. Receives: Drug: CDB+THC oil (MPL-005) |
| Placebo oil | Placebo comparator | Participants will receive matching placebo oil for a total duration of 12 weeks. Receives: Drug: Placebo oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome: pertaining to the patients recruitment
The ability to recruit the necessary number of patients during the estimated 12-month period
Measured: Through study completion, an average of 1 year
Feasibility outcome: pertaining to adherence to intervention
Defined as ≥70% of patients taking ≥70% of the prescribed doses and assessed from the participant-kept study drug diary data at each study visit.
Measured: Up to 12 weeks post-treatment
Feasibility outcome: pertaining to withdrawal from study
Participant withdrawal from the study <20%
Measured: Up to 12 weeks post-treatment
Feasibility outcome: pertaining to questionnaire data
The amount of missing data from all questionnaires <20%
Measured: Up to 12 weeks post-treatment
Feasibility outcome: the rate of unintentional unblinding
Defined as the participant correctly identifying group allocation and blinding success will be quantified using the BANG Index.
Measured: Up to 12 weeks post-treatment
Secondary outcomes (2)
The mean Morphine Equivalent (MEQ) dose (mg/day) at 12 weeks post-treatment for patients that were consuming opioids at the start of the trial
The data for opioid consumption will be extracted from the medical record or obtained via self report. MEQ will be calculated based on the 2017 Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain.
Measured: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
The mean pain interference at 12 weeks post-treatment
Pain interference will be assessed with The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a scale. This validated scale consists of 8 items detailing the extent to which pain interferes with the individual's abilities to perform and enjoy daily life; each item is rated on a 5-point scale (1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit and 5=very much). Scores are calculated from the total of item responses, with higher scores reflecting greater pain interference.
Measured: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start22 Nov 2022
- Primary completion31 Dec 2025
- Study completion12 Jan 2026
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.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive either a placebo, CBD oil (medical cannabis) or CBD+THC oil (medical cannabis) in a 1:1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hance Clarke, MD, PhD, Principal investigator, Toronto General Hospital, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351905
- Sponsor's protocol ID
- 19-5944
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Pilot, Randomized Controlled Trial of Oral Cannabinoids for Improving Pain Disability in Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT05351905
- Acronym / sponsor ID
- 19-5944
- Conditions
- Chronic Pain, Opioid Use, Cannabis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 28 Apr 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 investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. The results of this pilot study will help the study team design a larger randomized controlled trial.
Detailed description
Chronic pain is defined as pain lasting longer than three months, affects ~20% of Canadian adults. In addition to having a significant negative impact at the individual patient level (i.e., decreased quality of life and functioning), chronic pain is also a main cause of disability and health care use. Opioids are frequently prescribed to manage chronic pain despite limited data on their long term usefulness and has become one of the major contributors to the current opioid crisis in Canada. Chronic pain can potentially be treated with medical cannabis as an adjunct or alternative to opioids due to their similar behavioral, anatomical and biochemical mechanisms. Cannabinoids also potentially prevent the development of tolerance to opioids when co-administered.
Cannabinoids have demonstrated the ability to reduce pain as well as opioid-sparing effects in pre-clinical and clinical studies however further research is needed to identify the optimal make-up, ratio, and dosage of cannabinoids to minimize harms and maximize benefits. Furthermore, studies conducted to date have methodological problems such as short follow-up windows (hours or days) that limit conclusions. The investigators therefore propose a randomized, placebo-controlled trial of oral cannabinoids [CBD (cannabidiol) alone or in combination with THC (delta-9-tetrahydrocannabinol)] for reducing pain disability and opioid use for pain management in chronic pain. However, there are a number of feasibility issues that should be addressed prior to launching a full-scale trial in this area. Some issues have been identified in the literature (e.g., success of blinding) while others are related to the changing socio-medico-legal landscape surrounding cannabis use in Canada.
The purpose of this pilot study is to test the study plan, patient recruitment and compliance with the study procedures. Results of this study may be used as a guide for larger studies and will help us determine if medical cannabis can reduce daily opioid doses and/or decrease pain interference (disability) in chronic pain patients.
This study will aim to recruit 51 patients from the Toronto General Hospital Transitional Pain Service.
Study Procedure: After obtaining the Informed consent, patients will be randomized into one of the three study groups. Patients will either receive CBD oil, CBD+THC oil or placebo orally for 12 weeks. Starting dose will be 1 ml per day. The dose of study drug will be adjusted based on patients' reported efficacy and adverse effects. After starting the study drug, patients will have scheduled study visits either remotely or in-person at 4, 8, and 12 weeks plus a follow up calls or virtual clinic visit(OTN) at 2 and 6 weeks. At every study visit, patients will be asked to complete the questionnaires that will assess their pain level and how it affects their quality of life, opioid use, and side effects if they are experiencing. The investigators will also collect information on: demographic and baseline characteristics (e.g., sex, age, height, weight, and body mass index) and medical history (including prior and concomitant medications) via patient interview or from inspection of medical records. Additionally, symptoms of depression and anxiety will be measured with the validated screening tools at baseline and 12 weeks post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to receive either a placebo, CBD oil (medical cannabis) or CBD+THC oil (medical cannabis) in a 1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| CBD oil | Experimental | Drug: CBD oil ( MPL-001)Participants will receive CBD (cannabidiol) oil for a total duration of 12 weeks. |
| CBD+THC oil | Experimental | Drug: CDB+THC oil (MPL-005)Participants will receive CBD (cannabidiol) oil in combination with THC (delta-9-tetrahydrocannabinol) for a total duration of 12 weeks. |
| Placebo oil | Placebo comparator | Drug: Placebo oilParticipants will receive matching placebo oil for a total duration of 12 weeks. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 25 years
- Able to understand and read English
- Experiencing chronic, non-palliative pain
Key exclusion criteria (9 listed)
- Use of nabilone, nabiximols or cannabis in the 30 days preceding study recruitment
- Known allergy to cannabis or any cannabinoid
- Serious ongoing medical issues (i.e., lung, liver, kidney or heart disease) that in the opinion of the Investigator would compromise the safety of the patient
- Current uncontrolled serious mental disorders such as schizophrenia, or psychosis
- Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of child bearing potential during pretreatment evaluation)
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 |
|---|---|---|
| CBD oil ( MPL-001)Also: CBD concentrateMPL-001: which is a 25:1 Cannabidiol (CBD): ∆9-tetrahydrocannabidiol (THC) oral formulation with a concentration of 50 mg/ml of CBD and 2 mg/ml of THC. The starting dose will be 1 mL per day (50 mg CBD) orally and gradually titrated to a maximum dose of 6 mL (300 mg CBD) per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial. | Drug | CBD oil |
| CDB+THC oil (MPL-005)Also: CBD concentrateMPL-005: which is a 5:1 Cannabidiol (CBD):∆9-tetrahydrocannabidiol (THC) oral formulation with a concentration of 25 mg/ml of CBD and 5 mg/ml of THC. The starting dose will be 1 mL per day (25 mg CBD + 5 mg THC) orally and gradually titrated to a maximum dose of 6 mL (150 mg CBD + 30 mg THC) per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial. | Drug | CBD+THC oil |
| Placebo oilAlso: Matching placeboThe starting dose will be 1 mL per day (contains no API) orally and gradually titrated to a maximum dose of 6 mL per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial. | Drug | Placebo oil |
Primary outcome
Feasibility outcome: pertaining to the patients recruitment
Time frame: Through study completion, an average of 1 year
The ability to recruit the necessary number of patients during the estimated 12-month period
Feasibility outcome: pertaining to adherence to intervention
Time frame: Up to 12 weeks post-treatment
Defined as ≥70% of patients taking ≥70% of the prescribed doses and assessed from the participant-kept study drug diary data at each study visit.
Feasibility outcome: pertaining to withdrawal from study
Time frame: Up to 12 weeks post-treatment
Participant withdrawal from the study <20%
Feasibility outcome: pertaining to questionnaire data
Time frame: Up to 12 weeks post-treatment
The amount of missing data from all questionnaires <20%
Feasibility outcome: the rate of unintentional unblinding
Time frame: Up to 12 weeks post-treatment
Defined as the participant correctly identifying group allocation and blinding success will be quantified using the BANG Index.
2 secondary outcomes
The mean Morphine Equivalent (MEQ) dose (mg/day) at 12 weeks post-treatment for patients that were consuming opioids at the start of the trial
Time frame: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
The mean pain interference at 12 weeks post-treatment
Time frame: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Hance Clarke, MD, PhD principal investigator
Toronto General Hospital, UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD oil ( MPL-001) and CDB+THC oil (MPL-005) in people with Chronic Pain and Opioid Use, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jul 2026. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility outcome: pertaining to the patients recruitment (time frame: Through study completion, an average of 1 year). The study lists 5 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 22 Jul 2026.