Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05427630

Enrollment

Registered

2022-06-22

Start date

2023-02-15

Completion date

2027-12-01

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis, Migraine, THC

Keywords

Migraine, Cannabis, THC

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.

Interventions

DRUGTHC ~2.5%

Cannabis flower containing THC \~2.5%

DRUGTHC ~5%

Cannabis flower containing THC \~5%

DRUGTHC ~10%

Cannabis flower containing THC \~5%

DRUGSham Cannabis

Cannabis flower from which the THC and CBD have been extracted

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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."

Intervention model description

Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Headache Pain Freedom at 2 Hour Post-Treatment	2 Hours Post-Treatment	Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain

Secondary

Measure	Time frame	Description
Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment	2 Hours Post-Treatment	Dichotomous outcome of resolution of most bothersome symptom (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration
Headache Pain Relief at 2 Hours Post-Treatment	2 Hours Post-Treatment	Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNathaniel M Schuster, MD

Center for Pain Medicine, UC San Diego

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026