Chronic PainPhase 2NCT03337503
Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain
A Phase 2 study testing THC and CDB in a 1 to 1 ratio, Experimental: THC and CBD in a 1 to 2 ratio and High CBD with trace THC oil in people with Chronic Pain, run by Santé Cannabis at 1 site in Canada.
Trial summary
Seeking for effective therapeutic strategies, the investigators are proposing to test the effectiveness of different formulations of medical cannabis oil to alleviate chronic pain, which was partially relieved with conventional prescriptions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- THC and CDB in a 1 to 1 ratio, Experimental: THC and CBD in a 1 to 2 ratio and High CBD with trace THC oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2018to 15 Feb 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Adult patients (older than 18 years of age), male and female, with chronic non-cancer and cancer pain (at least 3 months in duration)
- Patients experiencing an average weekly pain intensity score greater than 4 on a 11 points NRS
- Subject agreed to follow the protocol
- Naïve cannabis patients with chronic non-cancer and cancer pain (not used cannabis in any presentation in the last 12 weeks)
- Patients receiving opioids and other concomitant pain medications should have a stable dose for the last 15 days.
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- Normal cognitive status according to MiniCog
- Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
- Normal renal function (defined as serum creatinine level <133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60)
- Negative result on βhuman chorionic gonadotropin pregnancy test (if applicable)
- Ability to read and respond to questions in French or English.
- A female volunteer must meet one of the following criteria:
- If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.
- If of non-childbearing potential - should be surgically sterile or in a menopausal state
- A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.
Who cannot join
- Acute pain (less than 3 months in duration)
- Previous serious adverse event or hypersensitivity to cannabis or cannabinoids
- Inability to understand and comply with the instructions of the study
- Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
- Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
- Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5
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- Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids
- Current or history of suicidal ideation
- Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception
- Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level >133 µmol/L, Estimated Glomerular Filtration Rate (eGFR) <60)
- Cognitive impairment according to MiniCog
- The patient is currently using or has used cannabinoid based medications within 90 days of study entry and is unwilling to abstain for the duration of the study
- Positive urine drug screen for cannabinoids and other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines, unprescribed opioids)
- Participation in another clinical trial within 30 days of enrolment in our trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain: a Randomized, Double-Blind, Placebo-Controlled Pilot Study, Followed by an Open-Label Extension Phase
Seeking for effective therapeutic strategies, the investigators are proposing to test the effectiveness of different formulations of medical cannabis oil to alleviate chronic pain, which was partially relieved with conventional prescriptions. Furthermore, the investigators would like to assess the effect of different formulations of medical cannabis oil on other symptoms associated to chronic pain like anxiety and depression, as well as insomnia and appetite. Finally, as recently recommended for clinical studies on medical cannabis, the investigators will examine the safety profile of different cannabis formulations focusing on the following elements: a real chronic administration with more than two weeks of treatment, a larger number of patients, and the clinical relevance of medical cannabis oil to change the amount and type of concomitant medications used to control chronic non-cancer and cancer pain.
Read the detailed description
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate the safety and efficacy of different formulations of medical cannabis oil to reduce chronic pain intensity.
The study will be conducted at Santé Cannabis Clinic, the only medical cannabinoid therapy clinic, located in Montreal, Quebec. One hundred and sixty consecutive adult patients, male and female, with chronic non-cancer and cancer pain (at least 3 months in duration), with an average weekly pain intensity score greater than 4 on the 11 points NRS, will be prospectively recruited and invited to participate in this trial.
Informed consent will be obtained by a Research Assistant.
After baseline documentation with standardized scales, patients will be randomized to one of 4 parallel groups:
- Group A: THC/CBD ratio 1:1 capsule
- Group B: THC/CBD ratio 1:2 capsule
- Group C: THC/CBD ratio 0.1:2 capsule
- Group D: Placebo capsule Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis.
Follow-up visits will be done after 1 week and 6 weeks of treatment. At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, the investigator may propose one of the cannabis oils to the subject if they feel it may potentially provide benefits.
They will take this new treatment for other 12 weeks. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
- Conditions
- Chronic Pain
- Being tested
- THC and CDB in a 1 to 1 ratio, Experimental: THC and CBD in a 1 to 2 ratio, High CBD with trace THC oil, placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC and CDB in a 1 to 1 ratioDrug
capsule containing cannabis oil
Experimental: THC and CBD in a 1 to 2 ratioDrug
capsule containing cannabis oil
High CBD with trace THC oilDrug
capsule containing cannabis oil
placeboOther
carrier oil capsule
| Study group | Role | What they receive |
|---|---|---|
| THC and CDB in a 1 to 1 ratio | Experimental | Post a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals.
2.5 mg THC with 2.5 mg CBD capsule Receives: Drug: THC and CDB in a 1 to 1 ratio |
| THC and CBD in a 1 to 2 ratio | Experimental | Post a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals.
2.5 mg THC with 5 mg CBD capsule Receives: Drug: Experimental: THC and CBD in a 1 to 2 ratio |
| high CBD with trace THC | Experimental | Post a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals.
20 mg CBD with traces of THC Receives: Drug: High CBD with trace THC oil |
| placebo | Placebo comparator | Post a self-titrating schedule of carrier oil, subjects take 1 capsule three times a day at 6 hour intervals.
carrier oil capsule Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does the daily use of cannabis oil improves chronic pain
Changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) scale. Scale range is 0 to 10; 0 (No pain) being the best rating to the maximal rating of 10 (Pain as bad as you can imagine).
Measured: Change from Baseline in BPI-SF at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improves chronic pain
Changes in pain as measured by the Numerical Rating Scale (NRS). The NRS is a measure of the average weekly pain intensity score greater than on a 0 to 10 points scale where 0 is No Pain and 10 is the worst pain.
Measured: Change from Baseline in NRS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Secondary outcomes (6)
Does the daily use of cannabis oil improve symptom burden
Changes in symptom burden as measured by the revised Edmonton Symptom Assessment System version with Constipation and Sleep was added to assess improvement in symptom burden (ESAS-r-CS). Scale range is 0 to 10; 0 (No symptom) being the best rating to the maximal rating of 10 (Worst possible score for symptom).
Measured: Change from Baseline in ESAS-r-CS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil reduce the severity of Treatment-Emergent Adverse Events (safety and tolerability).
Changes in validated UKU Side Effects Rating Scale for Patients (UKU-SERS-Pat). Scale range is 0 to 3 for rating the degree of severity and a second scale for the investigator that assigns a casual relationship of improbable, possible or probable.
Measured: Change from Baseline in UKU-SERSP at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve cognition
Changes in validated Mini-Cog. Scale range is numerical and rates the ability to recall words and ability to draw a clock showing numbers from 1 to 12 and then drawing the given time.
Measured: Change from Baseline in Mini-Cog at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil reduce the Profile of Mood States (POMS)
Changes in POMS . Scale range is 1 to 5 and describes how you feel right now. Scale of 1, the lowest score, describes a feeling of Not At All right now for the mood and the scale of 5 gives the highest score representing a feeling of Extremely for the mood.
Measured: Change from Baseline in POMS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve the Hamilton Rating Scale for Depression (HAM-D)
Changes in HAM-D scale. Scale range is either 0 to 2 or 0 to 4. The scale is designed to rate the severity of depression with a score of 0 representing the absence of the question and 2 or 4 meaning the highest severity.
Measured: Change from Baseline in HAM-D at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve Medication Quantification Scale (MQS) version III
Changes in concurrent medications, rescue medications and Medication Quantification Scale (MQS) version III. MQS is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed.
Measured: Change from Baseline in MQS version III at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start29 Jan 2018
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Why it stopped: Sponsor decision to stop the study
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santé Cannabis
- Sponsor type
- University, hospital or other
- Collaborators
- Tetra Bio-Pharma
- Responsible party
- Sponsor
- Investigators
- Antonio Vigano, MD, MSc, Principal investigator, McGill UniversityMaria Fernanda Arboleda, MD, Study director, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337503
- Sponsor's protocol ID
- Cannabis Oil Study PPP005-001
- Status last verified
- Apr 2024
- First submitted
- 17 Oct 2017
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain: a Randomized, Double-Blind, Placebo-Controlled Pilot Study, Followed by an Open-Label Extension Phase
- ClinicalTrials.gov ID
- NCT03337503
- Acronym / sponsor ID
- Cannabis Oil Study PPP005-001
- Conditions
- Chronic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to stop the study
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Santé CannabisUniversity, hospital or other
- Collaborators
- Tetra Bio-Pharma
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 9 Nov 2017 (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.
Seeking for effective therapeutic strategies, the investigators are proposing to test the effectiveness of different formulations of medical cannabis oil to alleviate chronic pain, which was partially relieved with conventional prescriptions. Furthermore, the investigators would like to assess the effect of different formulations of medical cannabis oil on other symptoms associated to chronic pain like anxiety and depression, as well as insomnia and appetite. Finally, as recently recommended for clinical studies on medical cannabis, the investigators will examine the safety profile of different cannabis formulations focusing on the following elements: a real chronic administration with more than two weeks of treatment, a larger number of patients, and the clinical relevance of medical cannabis oil to change the amount and type of concomitant medications used to control chronic non-cancer and cancer pain.
Detailed description
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate the safety and efficacy of different formulations of medical cannabis oil to reduce chronic pain intensity.
The study will be conducted at Santé Cannabis Clinic, the only medical cannabinoid therapy clinic, located in Montreal, Quebec. One hundred and sixty consecutive adult patients, male and female, with chronic non-cancer and cancer pain (at least 3 months in duration), with an average weekly pain intensity score greater than 4 on the 11 points NRS, will be prospectively recruited and invited to participate in this trial.
Informed consent will be obtained by a Research Assistant.
After baseline documentation with standardized scales, patients will be randomized to one of 4 parallel groups:
- Group A: THC/CBD ratio 1:1 capsule
- Group B: THC/CBD ratio 1:2 capsule
- Group C: THC/CBD ratio 0.1:2 capsule
- Group D: Placebo capsule Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis.
Follow-up visits will be done after 1 week and 6 weeks of treatment. At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, the investigator may propose one of the cannabis oils to the subject if they feel it may potentially provide benefits.
They will take this new treatment for other 12 weeks. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| THC and CDB in a 1 to 1 ratio | Experimental | Drug: THC and CDB in a 1 to 1 ratioPost a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals. 2.5 mg THC with 2.5 mg CBD capsule |
| THC and CBD in a 1 to 2 ratio | Experimental | Drug: Experimental: THC and CBD in a 1 to 2 ratioPost a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals. 2.5 mg THC with 5 mg CBD capsule |
| high CBD with trace THC | Experimental | Drug: High CBD with trace THC oilPost a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals. 20 mg CBD with traces of THC |
| placebo | Placebo comparator | Other: placeboPost a self-titrating schedule of carrier oil, subjects take 1 capsule three times a day at 6 hour intervals. carrier oil capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent
- Adult patients (older than 18 years of age), male and female, with chronic non-cancer and cancer pain (at least 3 months in duration)
- Patients experiencing an average weekly pain intensity score greater than 4 on a 11 points NRS
- Subject agreed to follow the protocol
- Naïve cannabis patients with chronic non-cancer and cancer pain (not used cannabis in any presentation in the last 12 weeks)
Key exclusion criteria (14 listed)
- Acute pain (less than 3 months in duration)
- Previous serious adverse event or hypersensitivity to cannabis or cannabinoids
- Inability to understand and comply with the instructions of the study
- Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
- Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
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 |
|---|---|---|
| THC and CDB in a 1 to 1 ratiocapsule containing cannabis oil | Drug | THC and CDB in a 1 to 1 ratio |
| Experimental: THC and CBD in a 1 to 2 ratiocapsule containing cannabis oil | Drug | THC and CBD in a 1 to 2 ratio |
| High CBD with trace THC oilcapsule containing cannabis oil | Drug | high CBD with trace THC |
| placebocarrier oil capsule | Other | placebo |
Primary outcome
Does the daily use of cannabis oil improves chronic pain
Time frame: Change from Baseline in BPI-SF at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) scale. Scale range is 0 to 10; 0 (No pain) being the best rating to the maximal rating of 10 (Pain as bad as you can imagine).
Does the daily use of cannabis oil improves chronic pain
Time frame: Change from Baseline in NRS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Changes in pain as measured by the Numerical Rating Scale (NRS). The NRS is a measure of the average weekly pain intensity score greater than on a 0 to 10 points scale where 0 is No Pain and 10 is the worst pain.
6 secondary outcomes
Does the daily use of cannabis oil improve symptom burden
Time frame: Change from Baseline in ESAS-r-CS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil reduce the severity of Treatment-Emergent Adverse Events (safety and tolerability).
Time frame: Change from Baseline in UKU-SERSP at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve cognition
Time frame: Change from Baseline in Mini-Cog at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil reduce the Profile of Mood States (POMS)
Time frame: Change from Baseline in POMS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve the Hamilton Rating Scale for Depression (HAM-D)
Time frame: Change from Baseline in HAM-D at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve Medication Quantification Scale (MQS) version III
Time frame: Change from Baseline in MQS version III at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Results and safety
The study was stopped early (reason given: Sponsor decision to stop the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Vigano, MD, MSc principal investigator
McGill University
Maria Fernanda Arboleda, MD study director
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THC and CDB in a 1 to 1 ratio, Experimental: THC and CBD in a 1 to 2 ratio and High CBD with trace THC oil in people with Chronic Pain, run by Santé Cannabis 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 15 inclusion and 14 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: stopped early, as of the sponsor's last update on 2 Dec 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to stop the 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?
Does the daily use of cannabis oil improves chronic pain (time frame: Change from Baseline in BPI-SF at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.). The study lists 2 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 2 Dec 2024.