Actively Recruiting

Phase 2
Age: 25Years +
All Genders
NCT03972124

Cannabis for the Prophylactic Treatment of Migraine

Led by University of Calgary · Updated on 2026-05-01

72

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Cannabis for the Prophylactic Treatment of Migraine

Who Can Participate

Age: 25Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give signed informed consent
  • Male or female aged 25 years or older
  • History of migraine diagnosed by International Classification of Headache Disorders for at least 12 months
  • Chronic migraine for at least 3 months before screening
  • Stable dose of migraine preventative medications for at least 3 months prior to randomization, with no planned changes during the study
  • Females of child-bearing age using reliable contraception
  • Failure of at least two prior migraine preventatives due to lack of efficacy or tolerability
  • Able to follow study procedures, complete headache diaries and questionnaires
  • Completion of at least 90% of headache diary during 1 month baseline period
Not Eligible

You will not qualify if you...

  • Presence of other active primary headaches (e.g., cluster headache, hemicrania continua)
  • Secondary headaches such as those related to intracranial hypertension, hypotension, hydrocephalus, or brain lesions
  • Pregnancy, planning pregnancy, or breastfeeding
  • Active or significant history of major mental illness including severe depression, anxiety, psychosis, or schizophrenia
  • History or current substance use disorder
  • Regular cannabis use in past 12 months
  • Significant cardiovascular or cerebrovascular disease (e.g., heart attack, stroke, peripheral vascular disease)
  • Untreated hypertension over 160/100
  • Past history of seizure disorder
  • Liver disease or elevated liver enzymes at baseline
  • Severe kidney disease or significantly reduced kidney function
  • Conditions causing excessive daytime sleepiness such as narcolepsy or sedative overuse
  • Any medical condition posing health risk as judged by investigators
  • Use of nerve blocks, sphenopalatine ganglion blocks, vagal nerve stimulators, or transcranial magnetic stimulators during baseline or treatment periods
  • Use of steroids or dihydroergotamine protocols during baseline or treatment periods
  • Overuse of triptans, dihydroergotamine, opioids, or barbiturates (10+ days/month in past 3 months)
  • Overuse of simple analgesics or NSAIDs (15+ days/month in past 3 months)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHAMP Research (Calgary Headache Assessment & Management Program)

Calgary, Alberta, Canada, T3M 1M4

Actively Recruiting

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Research Team

C

CHAMP Research (Calgary Headache Assessment & Management Prog)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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