MigrainePhase 2NCT04360044
Efficacy of Inhaled Cannabis for Acute Migraine Treatment
A Phase 2 study testing THC ~5%, CBD ~12% and THC ~5% and CBD ~12% in people with Migraine and Cannabis, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- What is being tested?
- THC ~5%, CBD ~12% and THC ~5% and CBD ~12%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 23 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment
- Pregnancy
- Breastfeeding
- Prisoner
- Known cognitive impairment
- Institutionalized
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Pain Medicine, UC San Diego
La Jolla, California, 92037
About this study
Official title: Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
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.
Read the 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.
- Being tested
- THC ~5%, CBD ~12%, THC ~5% and CBD ~12%, Sham Cannabis
- Keywords
- Migraine, Cannabis, THC, CBD
- Medical subject headings
- Migraine Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC ~5%Drug
Also called THC, delta 9-tetrahydrocannabinol, marijuana
4 puffs of vaporized flower containing THC ~5%
CBD ~12%Drug
Also called CBD, cannabidiol, hemp
4 puffs of vaporized flower containing CBD ~12%
THC ~5% and CBD ~12%Drug
Also called THC, CBD, delta 9-tetrahydrocannabinol, cannabidiol
4 puffs of vaporized flower containing THC ~5% and CBD ~12%
Sham CannabisDrug
Also called Placebo, Sham
4 puffs of vaporized flower from which the THC and CBD have been extracted
| Study group | Role | What they receive |
|---|---|---|
| THC ~5% | Experimental | 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). Receives: Drug: THC ~5% |
| THC ~5%/CBD ~12% | Experimental | 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). Receives: Drug: THC ~5% and CBD ~12% |
| CBD ~12% | Experimental | 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). Receives: Drug: CBD ~12% |
| Sham Cannabis | Sham comparator | 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). Receives: Drug: Sham Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Pain Relief at 2 Hours Post-Treatment
Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Measured: 2 Hours Post-Treatment
Secondary outcomes (2)
Headache pain freedom
Dichotomous endpoint of reduction from moderate/severe pain to no pain
Measured: 2 hours
Most bothersome symptom freedom
Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Nov 2020
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Double-blind, Placebo-controlled, Crossover Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Migraine Research Foundation
- Responsible party
- Principal investigator, Nathaniel Schuster, University of California, San Diego
- Investigators
- Nathaniel M Schuster, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360044
- Sponsor's protocol ID
- 2018 MRF Impact Award
- Status last verified
- Feb 2023
- First submitted
- 21 Apr 2020
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.
Publications
Schuster NM, Wallace MS, Marcotte TD, Buse DC, Lee E, Liu L, Sexton M. Vaporized cannabis versus placebo for acute migraine: A randomized, double-blind, placebo-controlled crossover trial. Headache. 2026 Feb;66(2):365-376. doi: 10.1111/head.70025. Epub 2025 Dec 30.
PubMed 41469488
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT04360044
- Acronym / sponsor ID
- 2018 MRF Impact Award
- Keywords
- Migraine, Cannabis, THC, CBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Migraine Research Foundation
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, Double-blind, Placebo-controlled, Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| THC ~5% | Experimental | Drug: 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). |
| THC ~5%/CBD ~12% | Experimental | Drug: THC ~5% and 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). |
| CBD ~12% | Experimental | Drug: 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). |
| Sham Cannabis | Sham comparator | Drug: Sham Cannabis4 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). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment
- Pregnancy
- Breastfeeding
- Prisoner
- Known cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THC ~5%Also: THC, delta 9-tetrahydrocannabinol, marijuana4 puffs of vaporized flower containing THC ~5% | Drug | THC ~5% |
| CBD ~12%Also: CBD, cannabidiol, hemp4 puffs of vaporized flower containing CBD ~12% | Drug | CBD ~12% |
| THC ~5% and CBD ~12%Also: THC, CBD, delta 9-tetrahydrocannabinol, cannabidiol4 puffs of vaporized flower containing THC ~5% and CBD ~12% | Drug | THC ~5%/CBD ~12% |
| Sham CannabisAlso: Placebo, Sham4 puffs of vaporized flower from which the THC and CBD have been extracted | Drug | Sham Cannabis |
Primary outcome
Headache Pain Relief at 2 Hours Post-Treatment
Time frame: 2 Hours Post-Treatment
Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain
2 secondary outcomes
Headache pain freedom
Time frame: 2 hours
Most bothersome symptom freedom
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 41469488Schuster NM, Wallace MS, Marcotte TD, Buse DC, Lee E, Liu L, Sexton M. Vaporized cannabis versus placebo for acute migraine: A randomized, double-blind, placebo-controlled crossover trial. Headache. 2026 Feb;66(2):365-376. doi: 10.1111/head.70025. Epub 2025 Dec 30.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel M Schuster, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THC ~5%, CBD ~12% and THC ~5% and CBD ~12% in people with Migraine and Cannabis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Pain Relief at 2 Hours Post-Treatment (time frame: 2 Hours Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.