Summary

Eligibility
for people ages 21-65 (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Nathaniel M Schuster, MD (ucsd)
Headshot of Nathaniel M Schuster
Nathaniel M Schuster

Description

Summary

This pilot crossover study will evaluate 3 different potencies of inhaled cannabis (2.5%, 5%, and 10%) and inhaled placebo cannabis for the acute treatment of migraine.

Official Title

Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial

Details

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 system. Subjects will self-administer inhaled cannabis as early as possible in the course of a migraine, taking 4 puffs of 1) THC 2.5%, 2) THC 5%, 3) THC 10%, or 4) placebo. Patients will treat each of the 4 distinct migraine attacks with a different cannabis sample. Outcomes measured will include pain freedom, most bothersome symptom (MBS), and pain relief as well as presence or absence of photophobia, phonophobia, and nausea at 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, and 48 hours.

Keywords

Migraine, Cannabis, THC, Migraine Disorders, Marijuana Abuse, Dronabinol, THC ~2.5%, THC ~5%, THC ~10%

Eligibility

Location

  • Center for Pain Medicine, UC San Diego
    La Jolla California 92037 United States

Lead Scientist at University of California Health

  • Nathaniel M Schuster, MD (ucsd)
    Associate Clinical Professor, Anesthesiology, Vc-health Sciences-schools. Authored (or co-authored) 46 research publications

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05427630
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated