Clinical trial NCT04360044: Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Official title: Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Cannabis
THC
CBD
Keywords: Migraine
Cannabis
THC
CBD
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Migraine Research Foundation
First posted: 2020-04-24
Enrollment: 92
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Double-blind, Placebo-controlled, Crossover Trial
Primary purpose: TREATMENT

Brief summary: This crossover study will evaluate 3 different treatments of vaporized cannabis (THC, THC/CBD mix, and CBD) and vaporized 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 vaporization system (Mighty Medic; Storz \& Bickel) based on a validated Storz \& Bickel system and using a standardized inhalation approach. Subjects will self-administer inhaled cannabis as early as possible in the course of a migraine (see Procedure), taking 4 puffs of 1) THC, 2) THC/CBD mix, 3) CBD, or 4) placebo. Patients will treat each of the 4 distinct migraine attacks with a different cannabis sample. Outcomes measured will include pain freedom and pain relief as well as presence or absence of photophobia, phonophobia, and nausea at 1 hour, 2 hours (primary outcome), 24 hours, and 48 hours.

Eligibility criteria: 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 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 or past adverse effects or negative past experiences from cannabis

Primary outcomes:
measure: Headache Pain Relief at 2 Hours Post-Treatment
timeFrame: 2 Hours Post-Treatment
Secondary outcomes:
measure: Headache pain freedom
timeFrame: 2 hours
measure: Most bothersome symptom freedom
timeFrame: 2 hours
Other outcomes:
measure: Headache pain relief
timeFrame: 1 hour, 24 hours, 48 hours
measure: Headache pain freedom
timeFrame: 1 hour, 24 hours, 48 hours
measure: Most bothersome symptom freedom
timeFrame: 1 hour, 24 hours, 48 hours
measure: Freedom from photophobia
timeFrame: 1 hour, 2 hours, 24 hours, 48 hours
measure: Freedom from phonophobia
timeFrame: 1 hour, 2 hours, 24 hours, 48 hours
measure: Freedom from nausea
timeFrame: 1 hour, 2 hours, 24 hours, 48 hours
measure: Freedom from vomiting
timeFrame: At any time over 48 hours
measure: Use of rescue medication
timeFrame: At any time over 48 hours
measure: Sustained pain freedom
timeFrame: 24 hours and 48 hours
measure: Sustained most bothersome symptom freedom
timeFrame: 24 hours and 48 hours
Locations:
city: La Jolla
country: United States
facility: Center for Pain Medicine, UC San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Nathaniel M Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References: