Overview

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