Efficacy of Inhaled Cannabis for Acute Migraine Treatment

Migraine Clinical Trial

Official title:

Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360044
• Other study ID #: 2018 MRF Impact Award
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2020
• Est. completion date: February 23, 2023

Study information

• Verified date: February 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• CBD
• Marijuana Abuse
• Migraine
• Migraine Disorders
• THC

Intervention

Drug:
• THC ~5%
4 puffs of vaporized flower containing THC ~5%
• CBD ~12%
4 puffs of vaporized flower containing CBD ~12%
• THC ~5% and CBD ~12%
4 puffs of vaporized flower containing THC ~5% and CBD ~12%
• Sham Cannabis
4 puffs of vaporized flower from which the THC and CBD have been extracted

Locations

Country	Name	City	State
United States	Center for Pain Medicine, UC San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Migraine Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Headache pain relief	Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain	1 hour, 24 hours, 48 hours
Other	Headache pain freedom	Dichotomous endpoint of reduction from moderate/severe pain to no pain	1 hour, 24 hours, 48 hours
Other	Most bothersome symptom freedom	Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration	1 hour, 24 hours, 48 hours
Other	Freedom from photophobia	Dichotomous endpoint of resolution of photophobia	1 hour, 2 hours, 24 hours, 48 hours
Other	Freedom from phonophobia	Dichotomous endpoint of resolution of phonophobia	1 hour, 2 hours, 24 hours, 48 hours
Other	Freedom from nausea	Dichotomous endpoint of resolution of nausea	1 hour, 2 hours, 24 hours, 48 hours
Other	Freedom from vomiting	Dichotomous endpoint of whether patient vomited during this migraine attack	At any time over 48 hours
Other	Use of rescue medication	Dichotomous endpoint of use of rescue medication	At any time over 48 hours
Other	Sustained pain freedom	Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain	24 hours and 48 hours
Other	Sustained most bothersome symptom freedom	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	24 hours and 48 hours
Primary	Headache Pain Relief at 2 Hours Post-Treatment	Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain	2 Hours Post-Treatment
Secondary	Headache pain freedom	Dichotomous endpoint of reduction from moderate/severe pain to no pain	2 hours
Secondary	Most bothersome symptom freedom	Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration	2 hours