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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Lisa L Patterson, BA contact

905-978-7908

pattersl@hhsc.ca

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

Other trials in Canada

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.

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 groups in NCT03635593
Study groupRoleWhat they receive
CBDActive comparator10mg capsules Cannabidiol (CBD)
Receives: Drug: CBD
CBD+THCActive comparator10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC)
Receives: Drug: CBD+THC
PlaceboPlacebo comparator10mg capsules placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted17 Aug 2018
  2. Study start1 Jan 2019 (estimated)
  3. Primary completion30 Jan 2021 (estimated)
  4. Study completion30 Jan 2021 (estimated)

Resources

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)
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

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.

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