Cannabis, CBD, Migraine, THC
Conditions
Keywords
Migraine, Cannabis, THC, CBD
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.
Interventions
DRUGTHC ~5%
4 puffs of vaporized flower containing THC \ 5%
DRUGCBD ~12%
4 puffs of vaporized flower containing CBD \ 12%
DRUGTHC ~5% and CBD ~12%
4 puffs of vaporized flower containing THC \ 5% and CBD \ 12%
DRUGSham Cannabis
4 puffs of vaporized flower from which the THC and CBD have been extracted
Sponsors
Migraine Research Foundation
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Each participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. The 4 treatments will be identically encapsulated by the study pharmacist using Storz & Bickel filling set. The study pharmacist will place the capsules in identical sealed plastic bags labeled Migraine 1 through Migraine 4.
Intervention model description
Randomized, Double-blind, Placebo-controlled, Crossover Trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Freedom from photophobia | 1 hour, 2 hours, 24 hours, 48 hours | Dichotomous endpoint of resolution of photophobia |
| Freedom from phonophobia | 1 hour, 2 hours, 24 hours, 48 hours | Dichotomous endpoint of resolution of phonophobia |
| Freedom from nausea | 1 hour, 2 hours, 24 hours, 48 hours | Dichotomous endpoint of resolution of nausea |
| Headache pain relief | 1 hour, 24 hours, 48 hours | Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain |
| Use of rescue medication | At any time over 48 hours | Dichotomous endpoint of use of rescue medication |
| Sustained pain freedom | 24 hours and 48 hours | Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain |
| Sustained most bothersome symptom freedom | 24 hours and 48 hours | Dichotomous endpoint of absence of most bothersome symptom at 2 hours afer dose, with no use of rescue medication and no relapse of most bothersome symptom |
| Freedom from vomiting | At any time over 48 hours | Dichotomous endpoint of whether patient vomited during this migraine attack |
| Headache pain freedom | 1 hour, 24 hours, 48 hours | Dichotomous endpoint of reduction from moderate/severe pain to no pain |
| Most bothersome symptom freedom | 1 hour, 24 hours, 48 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 |
Countries
United States
Outcome results
None listed