This study is currently not accepting new patients, but might later

Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

a study on Headache Migraine Cannabis THC

Eligibility: for people ages 21-65 (full criteria)
Location: at UCSD
Dates: study started February 2023
completion around June 2024
Principal Investigator: by Nathaniel M Schuster, MD (ucsd)

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

You can join if…

Open to people ages 21-65

Age ≥ 21 and ≤ 65
Able to communicate in English
Migraine, with or without aura, in its episodic or chronic manifestations, as per the International Headache Society (IHS) classification International Classification of Headache Disorders (ICHD-3) criteria (section 1.1, 1.2, 1.3).(48)
Ability to provide informed consent and complete website questionnaires in English
Agrees not to use cannabis outside of the study during participation in the study
Agrees not to use opioids or barbiturates during participation in the study
Agrees not to drive a motor vehicle within 4.5 hours following last use of inhaled cannabis during participation in the study

You CAN'T join if...

Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment
Pregnancy
Breastfeeding
Prisoner
Known cognitive impairment
Institutionalized
Current moderate-severe or severe depression
Current or past history of bipolar depression, schizophrenia, or psychosis
Current or past history of cannabis, alcohol, opioid, or amphetamine abuse or other substance use disorder at the discretion of the research team
Active pulmonary disease, class IV heart failure, cirrhosis, or other severe medical illnesses at the discretion of the research team.
Allergy to cannabis

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: February 2023
Completion Date: June 2024 (estimated)
Sponsor: University of California, San Diego
ID: NCT05427630
Phase: Phase 2 research study
Study Type: Interventional
Participants: Expecting 20 study participants
Last Updated: April 2024