Chronic Non-cancer PainPhase 2CONCEPTNCT03635593
Cannabis Oil for Chronic Non-Cancer Pain Treatment
A Phase 2 study testing CBD and CBD+THC in people with Chronic Non-cancer Pain, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Chronic Non-cancer Pain
- What is being tested?
- CBD and CBD+THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2019to 30 Jan 2021
- 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 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >25
- Average pain score in past week of ≥ 4/10.
Who cannot join
- Personal history of bipolar disorder
- Personal or family history (first degree relative - parent of sibling) of psychotic disorders (e.g., schizophrenia)
- Active cancer (an individual undergoing active cancer chemotherapy, radiation or surgical treatment and is deemed to not be in remission as per an oncologist's report)
- Intention to travel internationally during the trial
- Uncontrolled diabetes (A1C > 11)
- Cannabis use in the past 4 weeks (recreational or medicinal)
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- Current use of illicit drugs (e.g., cocaine)
- Current use of non-prescription opioids
- Unable to read and write in English
- Women who are currently pregnant or breast-feeding; or women of child-bearing age who plan to become pregnant during the trial period.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Michael G. DeGroote Pain Clinic
Hamilton, Ontario, L8N 3Z5
Lisa L Patterson, 905-978-7861, pattersl@hhsc.ca
Toronto Poly Clinic
Toronto, Ontario
Ashley Villarruel, ashley@tpclinic.com
About this study
Official title: Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial
Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. The cannabis plant (Cannabis sativa, Cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. The two active cannabinoids of interest in this trial are tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). The goal of this trial is to determine whether CBD or CBD+THC reduces the average pain in participants with chronic non-cancer pain. The investigators also aim to determine whether CBD or CBD+THC is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.
- Conditions
- Chronic Non-cancer Pain
- Being tested
- CBD, CBD+THC, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
Participants will be randomized to CBD 10mg capsules for 12 weeks. Participants will start with 1, CBD (10mg) capsule per day and self-titrate up to 8, 10mg CBD capsules (80mg) per day as needed.
CBD+THCDrug
Participants will be randomized to CBD+THC 10mg (CBD 5mg + THC) for 12 weeks. Participants will start with 1, 10mg CBD+THC (5mg+5mg) capsule per day and self- titrate up to 8, 10mg CBD+THC (5mg+5mg) capsules to a maximum of 80mg (40mg CBD + 40mg THC) per day as needed.
PlaceboOther
Participants randomized to placebo 10mg capsules for 12 weeks. Participants will start with 1, 10mg placebo capsule per day and self-titrate up to 8 10mg placebo capsules (80mg) per day.
| Study group | Role | What they receive |
|---|---|---|
| CBD | Active comparator | 10mg capsules Cannabidiol (CBD) Receives: Drug: CBD |
| CBD+THC | Active comparator | 10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC) Receives: Drug: CBD+THC |
| Placebo | Placebo comparator | 10mg capsules placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Score
Relative change in Average Pain Score measured by the Average Pain Score ( 0=No Pain and 10=Pain as bad as you can imagine) from the Numeric Rating Scale
Measured: 12 weeks after Treatment (Week 16 of trial)
Secondary outcomes (12)
Pain Severity Score
Decrease in Pain Severity Score measured by composite of 4 pain items (worst, least, average, now with 0=No Pain and 10=Pain as bad as you can imagine) (mean severity score) from the Brief Pain Inventory
Measured: Baseline, week 4, 8, 12 and 16
Pain Intensity Score
Improved Pain Intensity Score measured by mean of 7 severity items (general, activity, walking, work, mood, enjoyment of life, relations with others and sleep with 0=No Pain and 10=Pain as bad as you can imagine) from the Brief Pain Inventory
Measured: Baseline, week 4, 8, 12 and 16
Physical Functioning Score
Increase in Physical Functioning Score measured by the SF-36V2. 10 items in this scale represent levels and kinds of limitations between the extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling or stooping and walking moderate distances. One self-care item is included to represent limitations in self-care activities. This scale captures both the presence and existent of physical limitations using a three-level response continuum. Low scores indicate significant limitations in performing physical activities, while high scores reflect little or no such limitations.
Measured: Baseline, week 4, 8, 12 and 16
Mental Health Score
Increase in Mental Health (MH) Score measured by the SF-36V2. This 5-item scale includes one or more items from each of four major mental health dimensions (anxiety, depression, loss of behavioral/emotional control, and psychological wellbeing). Low scores on MH are indicative of frequent feelings of nervousness and depression, while high scores indicate feelings of peace, happiness, and calm all or most of the time.
Measured: Baseline, week 4, 8, 12 and 16
Social Functioning Score
Increase in Social Functioning (SF) Score measured by the SF-36V2. This 2-item scale assesses health-related effects on quantity and quality of social activities, asking specifically either physical or emotional problems on social activities. The degree to which physical and emotional problems interfere with normal social actives increases with decreasing SF scores. The lowest score is related to extreme or frequent interference with normal social actives due to physical and emotional problems; the highest score indicates that the individual performs normal social activities without interference from physical or emotional problems..
Measured: Baseline, week 4, 8, 12 and 16
Physical Health-related Role Limitations
Decrease in Physical Health-related Role Limitations measured by the SF-36V2. This 4-item scale covers an array of physical health-related role limitations, including a) limitations in the kind of work or other usual activities, b) reduction in the amount of time spend on work or other usual activities, c) difficulty performing work or other usual activities, and d) accomplishing less. Low scores on this scale reflect problems with work or other actives as a result of physical problems. High scores indicate little or no problems with work or other daily activities.
Measured: Baseline, week 4, 8, 12 and 16
Depression Score
Improvement in Depression score measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 depression severity is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: Baseline, week 4, 8, 12 and 16
Anxiety Score
Improvement in Depression score measured by the Generalized Anxiety Disorder (GAD-7). This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively.
Measured: Baseline, week 4, 8, 12 and 16
Sleep Quality
Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI).Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI). Seven question added to get total score (0-28). Score of 0-7 has no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia - moderate severity and 22-28 clinical insomnia - severe.
Measured: Baseline, week 4, 8, 12 and 16
Pain Medication
Decrease in prescription pain medication use. Measured by recording initial and changes in prescription medication names, dose and frequency
Measured: Baseline, week 4, 8, 12 and 16
Other non-pain prescription medications
Decrease in other no-pain prescription medications. Measured by recording initial and changes in non-prescription medications names, dose and frequency
Measured: Baseline, week 4, 8, 12 and 16
Average Pain Score
Relative change in Average Pain Score measured by the Average Pain Score ( 0=No Pain and 10=Pain as bad as you can imagine) from the Numeric Rating Scale
Measured: Baseline, week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-cancer 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramesh Zacharias, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635593
- Sponsor's protocol ID
- MGD-011-20180805
- Acronym
- CONCEPT
- Status last verified
- Nov 2018
- First submitted
- 15 Aug 2018
- Last updated
- 13 Nov 2018
- 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 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03635593
- Acronym / sponsor ID
- CONCEPT / MGD-011-20180805
- Conditions
- Chronic Non-cancer Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 17 Aug 2018 (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.
Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. The cannabis plant (Cannabis sativa, Cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. The two active cannabinoids of interest in this trial are tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). The goal of this trial is to determine whether CBD or CBD+THC reduces the average pain in participants with chronic non-cancer pain. The investigators also aim to determine whether CBD or CBD+THC is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBD | Active comparator | Drug: CBD10mg capsules Cannabidiol (CBD) |
| CBD+THC | Active comparator | Drug: CBD+THC10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC) |
| Placebo | Placebo comparator | Other: Placebo10mg capsules placebo |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >25
- Average pain score in past week of ≥ 4/10.
Key exclusion criteria (10 listed)
- Personal history of bipolar disorder
- Personal or family history (first degree relative - parent of sibling) of psychotic disorders (e.g., schizophrenia)
- Active cancer (an individual undergoing active cancer chemotherapy, radiation or surgical treatment and is deemed to not be in remission as per an oncologist's report)
- Intention to travel internationally during the trial
- Uncontrolled diabetes (A1C > 11)
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 |
|---|---|---|
| CBDParticipants will be randomized to CBD 10mg capsules for 12 weeks. Participants will start with 1, CBD (10mg) capsule per day and self-titrate up to 8, 10mg CBD capsules (80mg) per day as needed. | Drug | CBD |
| CBD+THCParticipants will be randomized to CBD+THC 10mg (CBD 5mg + THC) for 12 weeks. Participants will start with 1, 10mg CBD+THC (5mg+5mg) capsule per day and self- titrate up to 8, 10mg CBD+THC (5mg+5mg) capsules to a maximum of 80mg (40mg CBD + 40mg THC) per day as needed. | Drug | CBD+THC |
| PlaceboParticipants randomized to placebo 10mg capsules for 12 weeks. Participants will start with 1, 10mg placebo capsule per day and self-titrate up to 8 10mg placebo capsules (80mg) per day. | Other | Placebo |
Primary outcome
Average Pain Score
Time frame: 12 weeks after Treatment (Week 16 of trial)
Relative change in Average Pain Score measured by the Average Pain Score ( 0=No Pain and 10=Pain as bad as you can imagine) from the Numeric Rating Scale
12 secondary outcomes
Pain Severity Score
Time frame: Baseline, week 4, 8, 12 and 16
Pain Intensity Score
Time frame: Baseline, week 4, 8, 12 and 16
Physical Functioning Score
Time frame: Baseline, week 4, 8, 12 and 16
Mental Health Score
Time frame: Baseline, week 4, 8, 12 and 16
Social Functioning Score
Time frame: Baseline, week 4, 8, 12 and 16
Physical Health-related Role Limitations
Time frame: Baseline, week 4, 8, 12 and 16
Depression Score
Time frame: Baseline, week 4, 8, 12 and 16
Anxiety Score
Time frame: Baseline, week 4, 8, 12 and 16
Sleep Quality
Time frame: Baseline, week 4, 8, 12 and 16
Pain Medication
Time frame: Baseline, week 4, 8, 12 and 16
Other non-pain prescription medications
Time frame: Baseline, week 4, 8, 12 and 16
Average Pain Score
Time frame: Baseline, week 4, 8 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBD and CBD+THC in people with Chronic Non-cancer Pain, run by Hamilton Health Sciences Corporation at 2 sites 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 2 inclusion and 10 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa L Patterson, BA (905-978-7908, pattersl@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Score (time frame: 12 weeks after Treatment (Week 16 of trial)). 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 13 Nov 2018.