Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

NCT ID: NCT05427630

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-06-01

Brief 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.

Detailed 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.

Conditions

Migraine; Cannabis; THC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

THC ~2.5%

Inhalation of cannabis flower containing THC \~2.5%

Group Type: EXPERIMENTAL

THC ~2.5%

Intervention Type: DRUG

Cannabis flower containing THC \~2.5%

THC ~5%

Inhalation of cannabis flower containing THC \~5%

Group Type: EXPERIMENTAL

THC ~5%

Intervention Type: DRUG

Cannabis flower containing THC \~5%

THC ~10%

Inhalation of cannabis flower containing THC \~10%

Group Type: EXPERIMENTAL

THC ~10%

Intervention Type: DRUG

Cannabis flower containing THC \~5%

Sham Cannabis

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

Group Type: SHAM_COMPARATOR

Sham Cannabis

Intervention Type: DRUG

Cannabis flower from which the THC and CBD have been extracted

Interventions

THC ~2.5%

Cannabis flower containing THC \~2.5%

Intervention Type: DRUG

THC ~5%

Cannabis flower containing THC \~5%

Intervention Type: DRUG

THC ~10%

Cannabis flower containing THC \~5%

Intervention Type: DRUG

Sham Cannabis

Cannabis flower from which the THC and CBD have been extracted

Intervention Type: DRUG

Other Intervention Names

THC; delta 9-tetrahydrocannabinol; marijuana; THC; delta 9-tetrahydrocannabinol; marijuana; THC; delta 9-tetrahydrocannabinol; marijuana; Placebo; Sham

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Schuster

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaniel M Schuster, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Pain Medicine, UC San Diego

Locations

Center for Pain Medicine, UC San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

802999

Identifier Type: -

Identifier Source: org_study_id