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Cannabinoid

THC ~5% and CBD ~12% 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour, 2 hours, 24 hours, 48 hours
Awards & highlights

Study Summary

This trial will study whether cannabis can help relieve migraines.

Eligible Conditions
  • Migraine
  • Tetrahydrocannabinol
  • Cannabis
  • Cannabidiol

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour, 2 hours, 24 hours, 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour, 2 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 Relief 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%/CBD ~12%Experimental Treatment1 Intervention
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).
Group II: THC ~5%Experimental Treatment1 Intervention
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).
Group III: CBD ~12%Experimental Treatment1 Intervention
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).
Group IV: Sham CannabisPlacebo Group1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THC ~5% and CBD ~12%
2020
Completed Phase 2
~100
CBD ~12%
2020
Completed Phase 2
~100
THC ~5%
2020
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,126 Previous Clinical Trials
1,552,899 Total Patients Enrolled
2 Trials studying Migraine
117 Patients Enrolled for Migraine
Migraine Research FoundationOTHER
6 Previous Clinical Trials
200 Total Patients Enrolled
3 Trials studying Migraine
146 Patients Enrolled for Migraine
Nathaniel M Schuster, MDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Migraine
20 Patients Enrolled for Migraine

Frequently Asked Questions

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

Have there been any other investigations of a combination of THC at approximately 5% and CBD around 12%?

"Presently, 130 clinical trials are actively studying the effects of THC ~5% and CBD ~12%. Of these studies, 21 are in Phase 3. Although most research is based out of Ribeirao Preto, Sao Paulo, 373 locations host experiments related to this medication."

Answered by AI

What medical issues can be addressed through the use of a cannabis-derived solution containing around 5% THC and 12% CBD?

"Cannabinoids with a THC concentration of ~5% and CBD level measuring at ~12%, are typically administered to those who have not responded well to traditional treatments. It is also utilized for managing multiple sclerosis, pharmacotherapy, and various types of pain."

Answered by AI

What criteria must a participant meet in order to be accepted into this trial?

"This medical trial is searching for 92 participants aged 21 and 65 with the diagnosis of migraine, as outlined in ICHD-3. In addition to meeting this requirement, it's essential that individuals involved are able to communicate in English, understand the parameters of consenting to participate in the study, abstain from using cannabis outside of their participation in research activities, avoid taking opioids or barbiturates during involvement with the trial, and not drive a motor vehicle within four hours after inhaling cannabis."

Answered by AI

What potential risks are present when ingesting a combination of THC at 5% and CBD at 12%?

"Prior research has established preliminary safety for a formulation of THC ~5% and CBD ~12%, so it was assigned a score of 2. However, there is yet to be any evidence demonstrating its efficacy."

Answered by AI

Is recruitment for this trial currently open?

"Currently, this medical trial is not recruiting patients. Initially posted on November 20th 2020 and last updated four months ago, it requires no additional participants at the moment; however, there are 305 studies admitting people with THC and 130 trials involving a combination of 5% THC & 12% CBD actively enrolling individuals."

Answered by AI

Is there an age restriction for participants in this medical experiment?

"The age group being considered for this medical trial range from 21 years old to 65 years old."

Answered by AI

What is the participant cap of this research endeavor?

"At present, this clinical study is not recruiting. Initially posted on November 20th 2020 and recently updated on November 4th 2022, patients are encouraged to seek out other trials with similar criteria that are currently enrolling. To date, 305 studies involving THC have been identified as actively searching for participants, while 130 experiments regarding a combination of THC ~5% and CBD ~12% remain open-for-enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Nathaniel Schuster 2020. "Efficacy of Inhaled Cannabis for Acute Migraine Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04360044.
~21 spots leftby May 2025
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