Testing CBD against a placebo for chronic migraine
Official title: Cannabis for the Prophylactic Treatment of Migraine
Cannabis for the Prophylactic Treatment of Migraine: a Randomized Double-Blind Placebo-Controlled Clinical Trial
- Phase 2
- 3 groups
- One site, in Calgary
- Recruiting
Interventions
- Medication
CBD 100 mg OD
CBD oil - purified to \<1% THC in soft-gel capsules
- Medication
CBD 200 mg OD
CBD oil - purified to \<1% THC in soft-gel capsules
- Medication
Placebo
Soft-gel capsules containing placebo
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
CHAMP Research (Calgary Headache Assessment & Management Program)
Calgary, Alberta
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Subject is willing and able to give signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Male and female patients aged 25 years or older.
- +History of migraine for at least 12 months as diagnosed by the International Classification of Headache Disorders (ICHD-3).
- +Chronic migraine for at least the previous 3 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, as diagnosed by ICHD-3.
- +Migraine preventative medications (including Botulinum toxin injections) are permitted if dose is stable for the 3 month period prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, and no change to dose is planned for the entire duration of the study.
- +Failure of at least 2 prior migraine preventatives, either due to lack of efficacy with an appropriate trial of the medication, or due to lack of tolerability.
- +Able to follow study procedures, fill out headache diaries, and complete questionnaires.
- +Completion of at least 90% of the headache diary during the one month baselineBaselineYour starting measurements, taken before treatment begins.Read more → period.
- +Using a reliable method of contraception for females of child-bearing age.
Exclusion
- −Use of interventions or devices, such as nerve blocks, sphenopalatine ganglion blocks, vagal nerve stimulators, and transcranial magnetic stimulators during the baselineBaselineYour starting measurements, taken before treatment begins.Read more → period (weeks -4 to 0). These treatments will also be prohibited during the period of therapy (weeks 0 to 12).
- −Use of transitional therapies such as a course of steroids or a dihydroergotamine protocolProtocolThe detailed plan a study must follow.Read more → during the baseline period (weeks -4 to 0). These treatments will also be prohibited during the period of therapy (weeks 0 to 12).
- −Other active primary headaches, such as cluster headache, hemicrania continua, etc.
- −Any secondary headache, such as headache related to intracranial hypertension, intracranial hypotension, hydrocephalus, intracranial mass lesion, etc.
- −Active or significant history of major mental illness, including severe depression, or anxiety, and any history of psychosis or schizophrenia.
- −History of or current substance use disorder.
- −Regular use of cannabis for medical or recreational reasons during the previous 12 months.
- −History of significant cardiovascular or cerebrovascular disease, such as previous myocardial infarction, stroke, or peripheral vascular disease.
- −History of hypertension greater than 160/100 and not medically treated.
- −Any past history of seizure disorder.
- −Liver disease or liver enzymes two or more times the upper limit of normal at baseline.
- −Severe renal disease or GFR more than 30% below expected.
- −Any disorder or condition leading to hypersomnolence or excessive daytime drowsiness, such as narcolepsy, excessive use of sedatives/hypnotics, etc.
- −Any other medical condition that in the opinion of the investigators may pose a health risk to the subject if entered into the clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
- −Overuse of triptan, dihydroergotamine, opioid, or barbiturate medications, defined as 10 or more days per month in the 3 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Overuse of simple analgesics (such as acetaminophen, ibuprofen, aspirin), and non-steroidal anti-inflammatories (such as naproxen, ketorolac, diclofenac, etc.) defined as 15 or more days per month in the 3 months prior to randomization.
- −Pregnant, planning to become pregnant, or breastfeeding.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A, the comparison group, receives CBD 100 mg OD.
Registry label: A: CBD 100 mg OD
Group B receives CBD 200 mg OD.
Registry label: B: CBD 200 mg OD
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: C: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 25 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 72 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and weeks 9-12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The mean change in the number of headache days between the 4-week baselineBaselineYour starting measurements, taken before treatment begins.Read more → period compared to the 4-week period just preceding the 3 month follow-up visitFollow-upContinued check-ins after the treatment part is finished.Read more → — measured over Baseline and weeks 9-12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03972124 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CBD 100 mg ODDrug
CBD oil - purified to \<1% THC in soft-gel capsules
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CBD 200 mg ODDrug
CBD oil - purified to \<1% THC in soft-gel capsules
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Soft-gel capsules containing placebo
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 25 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 25 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and weeks 9-12.
The study as a whole is currently expected to finish around 2028-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 72 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study will evaluate the efficacy and safety of cannabis for the treatment of chronic migraine headaches. Study subjects will be randomized to one of three groups: lower dose CBD, higher dose CBD or placebo.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.