Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
- Conditions
- CannabisMigraineTHC
- Interventions
- Registration Number
- NCT05427630
- Lead Sponsor
- University of California, San Diego
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description THC ~2.5% THC ~2.5% Inhalation of cannabis flower containing THC \~2.5% THC ~10% THC ~10% Inhalation of cannabis flower containing THC \~10% THC ~5% THC ~5% Inhalation of cannabis flower containing THC \~5% Sham Cannabis Sham Cannabis Inhalation of cannabis flower from which the THC and CBD have been extracted
- Primary Outcome Measures
Name Time Method Headache Pain Freedom at 2 Hour Post-Treatment 2 Hours Post-Treatment Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain
- Secondary Outcome Measures
Name Time Method Headache Pain Relief at 2 Hours Post-Treatment 2 Hours Post-Treatment Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment 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
Trial Locations
- Locations (1)
Center for Pain Medicine, UC San Diego
🇺🇸La Jolla, California, United States