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Cannabinoid

Inhaled Cannabis for Migraine

Phase 2
Waitlist Available
Led By Nathaniel M Schuster, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Age ≥ 21 and ≤ 65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Awards & highlights

Study Summary

This trial will study the effects of inhaling different potencies of cannabis on migraine relief.

Who is the study for?
This trial is for adults aged 21-65 with migraines, who can communicate in English and consent to study terms. Participants must not use cannabis outside the study, drive within 4.5 hours after using it, or take opioids/barbiturates during the trial. Those with cognitive impairments, severe depression/illnesses, substance abuse history, or allergies to cannabis cannot join.Check my eligibility
What is being tested?
The study tests three different strengths of inhaled cannabis (2.5%, 5%, and 10%) against a placebo for immediate migraine relief. It's a crossover pilot study where participants will try each potency and the sham treatment at different times.See study design
What are the potential side effects?
Potential side effects may include typical reactions to cannabis such as dizziness, dry mouth, altered senses/perception, coordination issues, memory impairment and increased heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with migraine, following the IHS guidelines.
Select...
I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Headache Pain Freedom at 2 Hour Post-Treatment
Secondary outcome measures
Headache Pain Relief at 2 Hours Post-Treatment
Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment
Other outcome measures
Freedom from nausea
Freedom from phonophobia
Freedom from photophobia
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: THC ~5%Experimental Treatment1 Intervention
Inhalation of cannabis flower containing THC ~5%
Group II: THC ~2.5%Experimental Treatment1 Intervention
Inhalation of cannabis flower containing THC ~2.5%
Group III: THC ~10%Experimental Treatment1 Intervention
Inhalation of cannabis flower containing THC ~10%
Group IV: Sham CannabisPlacebo Group1 Intervention
Inhalation of cannabis flower from which the THC and CBD have been extracted
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,387 Total Patients Enrolled
2 Trials studying Migraine
189 Patients Enrolled for Migraine
Nathaniel M Schuster, MDPrincipal InvestigatorCenter for Pain Medicine, UC San Diego
1 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Migraine
92 Patients Enrolled for Migraine

Media Library

Migraine Research Study Groups: THC ~5%, Sham Cannabis, THC ~10%, THC ~2.5%
Migraine Clinical Trial 2023: THC ~10% Highlights & Side Effects. Trial Name: NCT05427630 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this research project?

"This clinical trial, posted on December 1st 2022 and last edited November 4th 2022, is no longer accepting participants. However, there are presently 297 other trials actively searching for volunteers."

Answered by AI

Do I meet the criteria to be part of this medical research?

"This study is seeking 20 individuals with migraine, aged between 21 and 65. Potential participants must meet the following requirements: be an English speaker, provide informed consent for the trial, abstain from opioids or barbiturates during participation in the study, not drive a motor vehicle 4.5 hours after inhaling cannabis as part of the trial and adhere to International Headache Society criteria when classifying their migraines (ICHD-3), while also refraining from recreational use of cannabis outside of this clinical trial."

Answered by AI

Is this clinical research open to elderly individuals?

"This medical experiment is seeking participants aged 21 or over, however those above 65 years are ineligible."

Answered by AI

What potential health risks are posed by the ingestion of THC at 2.5% concentration?

"Based on the available clinical data, THC ~2.5% was assessed as a 2 because it has only been trialed in Phase 2 studies and there is currently no information regarding its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Washington
California
How old are they?
18 - 65
What site did they apply to?
Center for Pain Medicine, UC San Diego
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
Nathaniel Schuster 2023. "Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05427630.
All > Migraine Headaches > Migraine
~1 spots leftby Jun 2024
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