Status:
COMPLETED
Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Migraine Research Foundation
Conditions:
Migraine
Cannabis
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
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 syst...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04360044
Start Date
November 20 2020
End Date
February 23 2023
Last Update
February 28 2023
Active Locations (1)
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1
Center for Pain Medicine, UC San Diego
La Jolla, California, United States, 92037