Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2024

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: THC ~2.5%
    • Inhalation of cannabis flower containing THC ~2.5%
  • Experimental: THC ~5%
    • Inhalation of cannabis flower containing THC ~5%
  • Experimental: THC ~10%
    • Inhalation of cannabis flower containing THC ~10%
  • Sham Comparator: Sham Cannabis
    • Inhalation of cannabis flower from which the THC and CBD have been extracted

Clinical Trial Outcome Measures

Primary Measures

  • Headache Pain Freedom at 2 Hour Post-Treatment
    • Time Frame: 2 Hours Post-Treatment
    • Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain

Secondary Measures

  • Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment
    • Time Frame: 2 Hours Post-Treatment
    • Dichotomous outcome of resolution of most bothersome symptom (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration
  • Headache Pain Relief at 2 Hours Post-Treatment
    • Time Frame: 2 Hours Post-Treatment
    • Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nathaniel Schuster, Associate Professor – University of California, San Diego
  • Overall Official(s)
    • Nathaniel M Schuster, MD, Principal Investigator, Center for Pain Medicine, UC San Diego
  • Overall Contact(s)
    • Phirum Nguyen, 858-822-3108, psnguyen@health.ucsd.edu

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