La Jolla, California 92037

  • CBD

Purpose:

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.


Study summary:

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.


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 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


NCT ID:

NCT04360044


Primary Contact:

Principal Investigator
Nathaniel M Schuster, MD
University of California, San Diego

Phirum Ngyuen
Phone: 858-822-3108
Email: psnguyen@health.ucsd.edu


Backup Contact:

N/A


Location Contact:

La Jolla, California 92037
United States

Nathaniel Schuster, MD
Phone: 858-822-0787
Email: nmschuster@health.ucsd.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 02, 2022

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