Clinical trial NCT05427630: Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
Official title: Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Migraine
Cannabis
THC
Keywords: Migraine
Cannabis
THC
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 20
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, Dose-ranging Trial
Primary purpose: TREATMENT

Brief 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.

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.

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 4.5 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

Primary outcomes:
measure: Headache Pain Freedom at 2 Hour Post-Treatment
timeFrame: 2 Hours Post-Treatment
Secondary outcomes:
measure: Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment
timeFrame: 2 Hours Post-Treatment
measure: Headache Pain Relief at 2 Hours Post-Treatment
timeFrame: 2 Hours Post-Treatment
Other outcomes:
measure: Headache pain freedom
timeFrame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
measure: Most bothersome symptom (MBS)
timeFrame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
measure: Headache pain relief
timeFrame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
measure: Freedom from photophobia
timeFrame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
measure: Freedom from phonophobia
timeFrame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
measure: Freedom from nausea
timeFrame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 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 (MBS)
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: Center for Pain Medicine, UC San Diego
name: Nathaniel M Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References: