This crossover study will evaluate 3 different treatments of vaporized cannabis (THC, THC/CBD mix, and CBD) and vaporized placebo cannabis for the acute treatment of migraine.
In this double-blind, randomized, crossover trial, subjects will treat 4 separate migraine attacks with 4 different treatments. Inhaled cannabis will be administered using a portable vaporization system (Mighty Medic; Storz \& Bickel) based on a validated Storz \& Bickel system and using a standardized inhalation approach. Subjects will self-administer inhaled cannabis as early as possible in the course of a migraine (see Procedure), taking 4 puffs of 1) THC, 2) THC/CBD mix, 3) CBD, or 4) placebo. Patients will treat each of the 4 distinct migraine attacks with a different cannabis sample. Outcomes measured will include pain freedom and pain relief as well as presence or absence of photophobia, phonophobia, and nausea at 1 hour, 2 hours (primary outcome), 24 hours, and 48 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Center for Pain Medicine, UC San Diego
La Jolla, California, United States
Headache Pain Relief at 2 Hours Post-Treatment
Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Time frame: 2 Hours Post-Treatment
Headache pain freedom
Dichotomous endpoint of reduction from moderate/severe pain to no pain
Time frame: 2 hours
Most bothersome symptom freedom
Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
Time frame: 2 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
4 puffs of vaporized flower from which the THC and CBD have been extracted