Recruiting
Phase 2

Cannabis

Sponsor:

University of Calgary

Code:

NCT03972124

Conditions

Chronic Migraine

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

CBD 100 mg OD

CBD 200 mg OD

Placebo

Study Details

Brief summary:

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.

Conditions

Chronic Migraine

Study ID

NCT03972124

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: CBD 100 mg OD

The lower dose CBD group will start with CBD capsules 10 mg OD, then increase the dose every 4 days until on the target dose of 100 mg OD.

experimental: CBD 200 mg OD

The higher dose CBD group will start with CBD capsules 10 mg OD and will increase every 4 days until on a target dose of 200 mg OD.

placebo comparator: Placebo

Interventions

CBD 100 mg OD

CBD oil - purified to <1% THC in soft-gel capsules

CBD 200 mg OD

CBD oil - purified to <1% THC in soft-gel capsules

Placebo

Soft-gel capsules containing placebo

Primary outcome measure

  • The mean change in the number of headache days between the 4-week baseline period compared to the 4-week period just preceding the 3 month follow-up visit. [ Time Frame: Baseline and weeks 9-12 ]

Central Contacts and Locations

Central contacts

CHAMP Research (Calgary Headache Assessment & Management Prog)

403-956-3427 or 403-956-3548champ.research@ucalgary.ca

Locations

CHAMP Research (Calgary Headache Assessment & Management Program)

Recruiting

Calgary, Alberta, Canada, T3M 1M4

Contacts

CHAMP Research (Calgary Headache Assessment & Management Prog)

403-956-3427 or 403-956-3548champ.research@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-01.