Efficacy of Inhaled Cannabis for Acute Migraine Treatment

NCT ID: NCT04360044

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2023-02-23

Brief Summary

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.

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 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.

Conditions

Migraine; Cannabis; THC; CBD

Study Design

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

Study Groups

THC ~5%

4 puffs of cannabis flower containing THC \~5% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Group Type: EXPERIMENTAL

THC ~5%

Intervention Type: DRUG

4 puffs of vaporized flower containing THC \~5%

THC ~5%/CBD ~12%

4 puffs of cannabis flower containing THC \~5% and CBD \~12% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Group Type: EXPERIMENTAL

THC ~5% and CBD ~12%

Intervention Type: DRUG

4 puffs of vaporized flower containing THC \~5% and CBD \~12%

CBD ~12%

4 puffs of cannabis flower containing CBD \~12% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Group Type: EXPERIMENTAL

CBD ~12%

Intervention Type: DRUG

4 puffs of vaporized flower containing CBD \~12%

Sham Cannabis

4 puffs of cannabis flower from which the THC and CBD have been extracted administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Group Type: SHAM_COMPARATOR

Sham Cannabis

Intervention Type: DRUG

4 puffs of vaporized flower from which the THC and CBD have been extracted

Interventions

THC ~5%

4 puffs of vaporized flower containing THC \~5%

Intervention Type: DRUG

CBD ~12%

4 puffs of vaporized flower containing CBD \~12%

Intervention Type: DRUG

THC ~5% and CBD ~12%

4 puffs of vaporized flower containing THC \~5% and CBD \~12%

Intervention Type: DRUG

Sham Cannabis

4 puffs of vaporized flower from which the THC and CBD have been extracted

Intervention Type: DRUG

Other Intervention Names

THC; delta 9-tetrahydrocannabinol; marijuana; CBD; cannabidiol; hemp; THC; CBD; delta 9-tetrahydrocannabinol; cannabidiol; marijuana; hemp; 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 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

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

Sponsors

Migraine Research Foundation

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Schuster

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaniel M Schuster, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Center for Pain Medicine, UC San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

2018 MRF Impact Award

Identifier Type: -

Identifier Source: org_study_id