Efficacy of Inhaled Cannabis for Acute Migraine Treatment
- Conditions
- MigraineCannabisTHCCBD
- Interventions
- Registration Number
- NCT04360044
- Lead Sponsor
- University of California, San Diego
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description THC ~5% THC ~5% 4 puffs of cannabis flower containing THC \~5% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA). CBD ~12% CBD ~12% 4 puffs of cannabis flower containing CBD \~12% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA). Sham Cannabis Sham Cannabis 4 puffs of cannabis flower from which the THC and CBD have been extracted administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA). THC ~5%/CBD ~12% THC ~5% and CBD ~12% 4 puffs of cannabis flower containing THC \~5% and CBD \~12% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).
- Primary Outcome Measures
Name Time Method Headache Pain Relief at 2 Hours Post-Treatment 2 Hours Post-Treatment Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain
- Secondary Outcome Measures
Name Time Method Headache pain freedom 2 hours Dichotomous endpoint of reduction from moderate/severe pain to no pain
Most bothersome symptom freedom 2 hours Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and 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