Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

NCT05427630 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: 802999
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Cannabis; THC

Keywords

Migraine; Cannabis; THC

Outcome Measures

Primary Outcomes (1)

• Headache Pain Freedom at 2 Hour Post-Treatment

  Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain

  2 Hours Post-Treatment

Secondary Outcomes (2)

• Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment

  2 Hours Post-Treatment

• Headache Pain Relief at 2 Hours Post-Treatment

  2 Hours Post-Treatment

Other Outcomes (10)

• Headache pain freedom

  15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours

• Most bothersome symptom (MBS)

  15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours

• Headache pain relief

  15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours

Study Arms (4)

THC ~2.5%

EXPERIMENTAL

Inhalation of cannabis flower containing THC \~2.5%

Drug: THC ~2.5%

THC ~5%

EXPERIMENTAL

Inhalation of cannabis flower containing THC \~5%

Drug: THC ~5%

THC ~10%

EXPERIMENTAL

Inhalation of cannabis flower containing THC \~10%

Drug: THC ~10%

Sham Cannabis

SHAM COMPARATOR

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

Drug: Sham Cannabis

Interventions

THC ~2.5% DRUG

Cannabis flower containing THC \~2.5%

Also known as: THC, delta 9-tetrahydrocannabinol, marijuana

THC ~2.5%

THC ~5% DRUG

Cannabis flower containing THC \~5%

Also known as: THC, delta 9-tetrahydrocannabinol, marijuana

THC ~5%

THC ~10% DRUG

Cannabis flower containing THC \~5%

Also known as: THC, delta 9-tetrahydrocannabinol, marijuana

THC ~10%

Sham Cannabis DRUG

Cannabis flower from which the THC and CBD have been extracted

Also known as: Placebo, Sham

Sham Cannabis

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Center for Pain Medicine, UC San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Marijuana Abuse

Interventions

Dronabinol; nabiximols; THC 5; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Nathaniel M Schuster, MD

  Center for Pain Medicine, UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. The 4 treatments will be identically encapsulated by the study pharmacist. The study pharmacist will place the capsules in identical sealed plastic bags labeled "Migraine 1" through "Migraine 4."
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 22, 2022
• Study Start: February 15, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 1 year and ending 5 years after article publication
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu

Locations

US (1)