Status:
SUSPENDED
Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
Lead Sponsor:
University of California, San Diego
Conditions:
Migraine
Cannabis
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05427630
Start Date
February 15 2023
End Date
June 1 2024
Last Update
April 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Pain Medicine, UC San Diego
La Jolla, California, United States, 92037