Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cannabis
- CBD
- Migraine
- THC
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Randomized, Double-blind, Placebo-controlled, Crossover TrialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Each participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. The 4 treatments will be identically encapsulated by the study pharmacist using Storz & Bickel filling set. The study pharmacist will place the capsules in identical sealed plastic bags labeled "Migraine 1" through "Migraine 4."Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Both males and females
Description
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 standardize...
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.
Tracking Information
- NCT #
- NCT04360044
- Collaborators
- Migraine Research Foundation
- Investigators
- Principal Investigator: Nathaniel M Schuster, MD University of California, San Diego
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