MigrainePhase 2NCT05427630
Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
A Phase 2 study testing THC ~2.5%, THC ~5% and THC ~10% in people with Migraine and Cannabis, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- What is being tested?
- THC ~2.5%, THC ~5% and THC ~10%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 1 Dec 2027
- 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 4.5 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
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- 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
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: Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
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.
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 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.
- Being tested
- THC ~2.5%, THC ~5%, THC ~10%, Sham Cannabis
- Keywords
- Migraine, Cannabis, THC
- 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 ~2.5%Drug
Also called THC, delta 9-tetrahydrocannabinol, marijuana
Cannabis flower containing THC ~2.5%
THC ~5%Drug
Also called THC, delta 9-tetrahydrocannabinol, marijuana
Cannabis flower containing THC ~5%
THC ~10%Drug
Also called THC, delta 9-tetrahydrocannabinol, marijuana
Cannabis flower containing THC ~5%
Sham CannabisDrug
Also called Placebo, Sham
Cannabis flower from which the THC and CBD have been extracted
| Study group | Role | What they receive |
|---|---|---|
| THC ~2.5% | Experimental | Inhalation of cannabis flower containing THC ~2.5% Receives: Drug: THC ~2.5% |
| THC ~5% | Experimental | Inhalation of cannabis flower containing THC ~5% Receives: Drug: THC ~5% |
| THC ~10% | Experimental | Inhalation of cannabis flower containing THC ~10% Receives: Drug: THC ~10% |
| Sham Cannabis | Sham comparator | Inhalation of cannabis flower from which the THC and CBD have been extracted Receives: Drug: Sham Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Pain Freedom at 2 Hour Post-Treatment
Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain
Measured: 2 Hours Post-Treatment
Secondary outcomes (2)
Most Bothersome Symptom (MBS) Freedom at 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
Measured: 2 Hours Post-Treatment
Headache Pain Relief at 2 Hours Post-Treatment
Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Measured: 2 Hours Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start15 Feb 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Why it stopped: Inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Dose-ranging Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaniel Schuster, University of California, San Diego
- Investigators
- Nathaniel M Schuster, MD, Principal investigator, Center for Pain Medicine, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427630
- Sponsor's protocol ID
- 802999
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2022
- Last updated
- 16 Mar 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
- ClinicalTrials.gov ID
- NCT05427630
- Acronym / sponsor ID
- 802999
- Keywords
- Migraine, Cannabis, THC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Inadequate funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Jun 2022 (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 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.
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, Dose-ranging Trial
| Arm | Type | Receives |
|---|---|---|
| THC ~2.5% | Experimental | Drug: THC ~2.5%Inhalation of cannabis flower containing THC ~2.5% |
| THC ~5% | Experimental | Drug: THC ~5%Inhalation of cannabis flower containing THC ~5% |
| THC ~10% | Experimental | Drug: THC ~10%Inhalation of cannabis flower containing THC ~10% |
| Sham Cannabis | Sham comparator | Drug: Sham CannabisInhalation of cannabis flower from which the THC and CBD have been extracted |
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 ~2.5%Also: THC, delta 9-tetrahydrocannabinol, marijuanaCannabis flower containing THC ~2.5% | Drug | THC ~2.5% |
| THC ~5%Also: THC, delta 9-tetrahydrocannabinol, marijuanaCannabis flower containing THC ~5% | Drug | THC ~5% |
| THC ~10%Also: THC, delta 9-tetrahydrocannabinol, marijuanaCannabis flower containing THC ~5% | Drug | THC ~10% |
| Sham CannabisAlso: Placebo, ShamCannabis flower from which the THC and CBD have been extracted | Drug | Sham Cannabis |
Primary outcome
Headache Pain Freedom at 2 Hour Post-Treatment
Time frame: 2 Hours Post-Treatment
Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain
2 secondary outcomes
Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment
Time frame: 2 Hours Post-Treatment
Headache Pain Relief at 2 Hours Post-Treatment
Time frame: 2 Hours Post-Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- 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
Center for Pain Medicine, UC 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 ~2.5%, THC ~5% and THC ~10% 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: paused, as of the sponsor's last update on 16 Mar 2026. 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?
Results are not available in the source record.
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 Freedom at 2 Hour 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?
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 16 Mar 2026.