Cannabis for Acute Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 04/20/2020 |
| Estimated Enrollment Submitted: | 04/20/2020 |
| First Posted: | 04/23/2020 |
| Last Update Submitted: | 04/20/2020 |
| Last Update Posted: | 04/23/2020 |
| Actual Study Start Date: | 05/31/2020 |
| Estimated Primary Completion Date: | 11/30/2021 |
| Estimated Study Completion Date: | 11/30/2021 |
Condition or disease
Intervention/treatment
Drug: THC ~4%
Drug: CBD ~6%
Drug: THC ~4%/CBD ~6%
Drug: Sham Cannabis
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: THC ~4% 4 puffs of cannabis flower containing THC ~4% 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). | Drug: THC ~4% 4 puffs of vaporized flower containing THC ~4% |
| Experimental: THC ~4%/CBD ~6% 4 puffs of cannabis flower containing THC ~4% and CBD ~6% 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). | Drug: THC ~4%/CBD ~6% 4 puffs of vaporized flower containing THC ~4% and CBD ~6% |
| Experimental: CBD ~6% 4 puffs of cannabis flower containing CBD ~6% 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). | Drug: CBD ~6% 4 puffs of vaporized flower containing CBD ~6% |
| Sham Comparator: 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). | Drug: Sham Cannabis 4 puffs of vaporized flower from which the THC and CBD have been extracted |
Eligibility Criteria
| Ages Eligible for Study | 21 Years To 21 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion criteria: - Age ≥ 21 or ≤ 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 - Prior THC-containing cannabis experience within the past two years - 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 - Inability to complete 28-day headache diary - 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 |
Outcome
Primary Outcome Measures
1. Headache Pain Relief at 2 Hours Post-Treatment [2 Hours Post-Treatment]
Secondary Outcome Measures
1. Headache pain freedom [2 hours]
2. Most bothersome symptom freedom [2 hours]
Other Outcome Measures
1. Headache pain relief [1 hour, 24 hours, 48 hours]
2. Headache pain freedom [1 hour, 24 hours, 48 hours]
3. Most bothersome symptom freedom [1 hour, 24 hours, 48 hours]
4. Freedom from photophobia [1 hour and 2 hours]
5. Freedom from phonophobia [1 hour and 2 hours]
6. Use of rescue medication [At any time over 48 hours]
7. Sustained pain freedom [24 hours and 48 hours]
8. Sustained most bothersome symptom freedom [24 hours and 48 hours]
