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Can CBD oil stop migraines before they start? new trial aims to find out
NCT ID NCT03972124
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether CBD oil (a non-psychoactive cannabis compound) can prevent chronic migraines. About 72 adults with frequent migraines will receive either a low dose of CBD, a higher dose, or a placebo for several months. Researchers will track changes in headache days to see if CBD works better than a dummy pill.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CBD oil (cannabidiol, purified to less than 1% THC)
- What this could lead to
- If it works, this could provide a new, non-psychoactive option for preventing chronic migraines with fewer side effects than current medications.
- What could go wrong
- This is a small, early-phase trial (72 people), so results may not apply to everyone. CBD may not reduce headache days more than placebo, and long-term safety is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject is willing and able to give signed informed consent. * 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 screening, 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 randomization, and no change to dose is planned for the entire duration of the study. * Using a reliable method of contraception for females of child-bearing age. * 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 baseline period. Exclusion Criteria: * 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. * Pregnant, planning to become pregnant, or breastfeeding. * 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 trial. * Use of interventions or devices, such as nerve blocks, sphenopalatine ganglion blocks, vagal nerve stimulators, and transcranial magnetic stimulators during the baseline 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 protocol during the baseline period (weeks -4 to 0). These treatments will also be prohibited during the period of therapy (weeks 0 to 12). * Overuse of triptan, dihydroergotamine, opioid, or barbiturate medications, defined as 10 or more days per month in the 3 months prior to randomization. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHAMP Research (Calgary Headache Assessment & Management Program)
RECRUITINGCalgary, Alberta, T3M 1M4, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could an inhaled sedative quiet the Brain's migraine alarm?
- Can neck exercises turn down the volume on chronic migraine?
- Can a No-Fridge migraine shot replace botox?
- Could a common cholesterol drug stop chronic migraine?
- Migraine relief may sharpen the mind: study investigates cognitive benefits of preventive therapies