Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

University of California San Diego

Status and phase: Suspended; Phase 2

Conditions: THC; Cannabis; Migraine

Treatments: Drug: Sham Cannabis; Drug: THC ~2.5%; Drug: THC ~5%; Drug: THC ~10%

Study type: Interventional

Funder types: Other

Identifiers

NCT05427630

802999

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups

THC ~2.5%

Experimental group

Description:

Inhalation of cannabis flower containing THC \~2.5%

Treatment:

Drug: THC ~2.5%

THC ~5%

Experimental group

Description:

Inhalation of cannabis flower containing THC \~5%

Treatment:

Drug: THC ~5%

THC ~10%

Experimental group

Description:

Inhalation of cannabis flower containing THC \~10%

Treatment:

Drug: THC ~10%

Sham Cannabis

Sham Comparator group

Description:

Inhalation of cannabis flower from which the THC and CBD have been extracted

Treatment:

Drug: Sham Cannabis