Cannabis Treatment for Migraine

Exclusion criteria:

1. Other active primary headaches, such as cluster headache, hemicrania continua, etc.
2. Any secondary headache, such as headache related to intracranial hypertension, intracranial hypotension, hydrocephalus, intracranial mass lesion, etc.
3. Pregnant, planning to become pregnant, or breastfeeding.
4. Active or significant history of major mental illness, including severe depression, or anxiety.
5. Personal history of psychosis or schizophrenia, hospital admission for psychosis, or first degree relative with schizophrenia.
6. History of or current substance use disorder. Urine drug screen will be performed at Visits 1 and 2.
7. Regular use of cannabis (weekly or more frequent), for medical or recreational reasons during the previous 3 months. Patients will also not be permitted to use cannabis or any cannabis products for the full duration of the study.
8. History of significant cardiovascular or cerebrovascular disease, such as previous myocardial infarction, stroke, or peripheral vascular disease.
9. History of hypertension greater than 160/100 and not medically treated.
10. Any past history of seizure disorder.
11. Liver disease or liver enzymes two or more times the upper limit of normal at baseline.
12. Moderate to severe renal disease or estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2. The equation used to estimate eGFR is the CKD-EPI equation.
13. Any disorder or condition leading to hypersomnolence or excessive daytime drowsiness, such as narcolepsy, excessive use of sedatives/hypnotics, etc.
14. 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.
15. 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).
16. 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).
17. Overuse of triptan, dihydroergotamine, opioid, or barbiturate medications, defined as 10 or more days per month in the 3 months prior to randomization.
18. 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.
19. Use of the following medications during the baseline period (weeks -4 to 0) and throughout the study:
- Strong or moderate CYP3A4 inhibitors, or strong CYP3A4 inducers.
- Strong or moderate CYP2C19 inhibitors, or strong CYP2C19 inducers.
- Study participants should also refrain from consuming grapefruit or grapefruit juice throughout the duration of this study.
21. Known allergy to any component of the capsule or investigational product.
22. Patients who must drive in the 10 hours following administration of the study drug will not be allowed to participate in this study. Study participants must refrain from driving or operating machinery for a minimum of 10 hours following the administration of the study drug and must exercise judgement beyond 10 hours. If there is impairment beyond 10 hours, then patients must continue not to drive until which time impairment fully resolves.