Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

University of California, San Diego20 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Migraine Cannabis THC

Interventions

THC ~2.5%DRUG

Cannabis flower containing THC \~2.5%

THC ~5%DRUG

Cannabis flower containing THC \~5%

THC ~10%DRUG

Cannabis flower containing THC \~5%

Sham Cannabis

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Pain Medicine, UC San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

Headache Pain Freedom at 2 Hour Post-Treatment

Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain

Time frame: 2 Hours Post-Treatment

Secondary Outcomes

Most Bothersome Symptom (MBS) Freedom at 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

Time frame: 2 Hours Post-Treatment

Headache Pain Relief at 2 Hours Post-Treatment

Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain

Time frame: 2 Hours Post-Treatment

Data from ClinicalTrials.gov

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