Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Dronabinol

Criteria

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