Summary

Eligibility
for people ages 21-65 (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Nathaniel M Schuster, MD
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

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 UCSD

  • Nathaniel M Schuster, MD
    Associate Clinical Professor, Anesthesiology, Vc-health Sciences-schools. Authored (or co-authored) 31 research publications

Details

Status
not yet accepting patients
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