NCT05427630

Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Migraine
• Cannabis
• THC

Interventions

Type	Name	Description
DRUG	THC ~2.5%	Cannabis flower containing THC \~2.5%
DRUG	THC ~5%	Cannabis flower containing THC \~5%
DRUG	THC ~10%	Cannabis flower containing THC \~5%
DRUG	Sham Cannabis	Cannabis flower from which the THC and CBD have been extracted

Timeline

• Start date: 2023-02-15
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-06-22
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study