Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05427630
• Other study ID #: 802999
• Status: Suspended
• Phase: Phase 2
• Start date: February 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• 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 4.5 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 to cannabis

Related Conditions & MeSH terms

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

Intervention

Drug:
• THC ~2.5%
Cannabis flower containing THC ~2.5%
• THC ~5%
Cannabis flower containing THC ~5%
• THC ~10%
Cannabis flower containing THC ~5%
• Sham Cannabis
Cannabis 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 (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Headache pain freedom	Dichotomous outcome of reduction from moderate/severe to no pain	15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Other	Most bothersome symptom (MBS)	Dichotomous outcome of resolution of MBS (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration	15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Other	Headache pain relief	Dichotomous outcome of reduction from moderate/severe to mild/no pain	15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Other	Freedom from photophobia	Dichotomous outcome of resolution of photophobia	15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Other	Freedom from phonophobia	Dichotomous outcome of resolution of phonophobia	15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Other	Freedom from nausea	Dichotomous outcome of resolution of nausea	15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Other	Freedom from vomiting	Dichotomous outcome of whether patient vomited during this migraine attack	At any time over 48 hours
Other	Use of rescue medication	Dichotomous outcome of use of rescue medication	At any time over 48 hours
Other	Sustained pain freedom	Dichotomous outcome of absence of headache pain at 2 hours after dose, with no use of rescue medication and no recurrence of headache pain	24 hours and 48 hours
Other	Sustained most bothersome symptom freedom (MBS)	Dichotomous outcome of absence of MBS at 2 hours after dose, with no use of rescue medication and no recurrence of MBS	24 hours and 48 hours
Primary	Headache Pain Freedom at 2 Hour Post-Treatment	Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain	2 Hours Post-Treatment
Secondary	Most Bothersome Symptom (MBS) Freedom at 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	2 Hours Post-Treatment
Secondary	Headache Pain Relief at 2 Hours Post-Treatment	Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain	2 Hours Post-Treatment