THC ~5%
4 puffs of vaporized flower containing THC \~5%
THC · delta 9-tetrahydrocannabinol · marijuanaLoading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-02-28
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
4 puffs of vaporized flower containing THC \~5%
THC · delta 9-tetrahydrocannabinol · marijuana4 puffs of vaporized flower containing CBD \~12%
CBD · cannabidiol · hemp4 puffs of vaporized flower containing THC \~5% and CBD \~12%
THC · CBD · delta 9-tetrahydrocannabinol · cannabidiol · marijuana · hemp4 puffs of vaporized flower from which the THC and CBD have been extracted
Placebo · ShamEligibility
primary outcomes
Time frame: 2 Hours Post-Treatment
Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain
secondary outcomes
Time frame: 2 hours
Dichotomous endpoint of reduction from moderate/severe pain to no pain
Time frame: 2 hours
Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
other outcomes
Time frame: 1 hour, 24 hours, 48 hours
Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain
Time frame: 1 hour, 24 hours, 48 hours
Dichotomous endpoint of reduction from moderate/severe pain to no pain
Time frame: 1 hour, 24 hours, 48 hours
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: 1 hour, 2 hours, 24 hours, 48 hours
Dichotomous endpoint of resolution of photophobia
Time frame: 1 hour, 2 hours, 24 hours, 48 hours
Dichotomous endpoint of resolution of phonophobia
Time frame: 1 hour, 2 hours, 24 hours, 48 hours
Dichotomous endpoint of resolution of nausea
Time frame: At any time over 48 hours
Dichotomous endpoint of whether patient vomited during this migraine attack
Time frame: At any time over 48 hours
Dichotomous endpoint of use of rescue medication
Time frame: 24 hours and 48 hours
Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain
Time frame: 24 hours and 48 hours
Dichotomous endpoint of absence of most bothersome symptom at 2 hours afer dose, with no use of rescue medication and no relapse of most bothersome symptom
Publications