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Efficacy of Inhaled Cannabis for Acute Migraine Treatment

Primary Purpose

Migraine, Cannabis, THC

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
THC ~5%
CBD ~12%
THC ~5% and CBD ~12%
Sham Cannabis
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Cannabis, THC, CBD

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 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 or past adverse effects or negative past experiences from cannabis

Sites / Locations

  • Center for Pain Medicine, UC San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

THC ~5%

THC ~5%/CBD ~12%

CBD ~12%

Sham Cannabis

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Headache Pain Relief at 2 Hours Post-Treatment
Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain

Secondary Outcome Measures

Headache pain freedom
Dichotomous endpoint of reduction from moderate/severe pain to no pain
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

Full Information

First Posted
April 21, 2020
Last Updated
February 24, 2023
Sponsor
University of California, San Diego
Collaborators
Migraine Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04360044
Brief Title
Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Official Title
Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Migraine Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Cannabis, THC, CBD
Keywords
Migraine, Cannabis, THC, CBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomized, Double-blind, Placebo-controlled, Crossover Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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 using Storz & Bickel filling set. The study pharmacist will place the capsules in identical sealed plastic bags labeled "Migraine 1" through "Migraine 4."
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THC ~5%
Arm Type
Experimental
Arm Description
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).
Arm Title
THC ~5%/CBD ~12%
Arm Type
Experimental
Arm Description
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).
Arm Title
CBD ~12%
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham Cannabis
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
THC ~5%
Other Intervention Name(s)
THC, delta 9-tetrahydrocannabinol, marijuana
Intervention Description
4 puffs of vaporized flower containing THC ~5%
Intervention Type
Drug
Intervention Name(s)
CBD ~12%
Other Intervention Name(s)
CBD, cannabidiol, hemp
Intervention Description
4 puffs of vaporized flower containing CBD ~12%
Intervention Type
Drug
Intervention Name(s)
THC ~5% and CBD ~12%
Other Intervention Name(s)
THC, CBD, delta 9-tetrahydrocannabinol, cannabidiol, marijuana, hemp
Intervention Description
4 puffs of vaporized flower containing THC ~5% and CBD ~12%
Intervention Type
Drug
Intervention Name(s)
Sham Cannabis
Other Intervention Name(s)
Placebo, Sham
Intervention Description
4 puffs of vaporized flower from which the THC and CBD have been extracted
Primary Outcome Measure Information:
Title
Headache Pain Relief at 2 Hours Post-Treatment
Description
Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Time Frame
2 Hours Post-Treatment
Secondary Outcome Measure Information:
Title
Headache pain freedom
Description
Dichotomous endpoint of reduction from moderate/severe pain to no pain
Time Frame
2 hours
Title
Most bothersome symptom freedom
Description
Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
Time Frame
2 hours
Other Pre-specified Outcome Measures:
Title
Headache pain relief
Description
Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain
Time Frame
1 hour, 24 hours, 48 hours
Title
Headache pain freedom
Description
Dichotomous endpoint of reduction from moderate/severe pain to no pain
Time Frame
1 hour, 24 hours, 48 hours
Title
Most bothersome symptom freedom
Description
Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
Time Frame
1 hour, 24 hours, 48 hours
Title
Freedom from photophobia
Description
Dichotomous endpoint of resolution of photophobia
Time Frame
1 hour, 2 hours, 24 hours, 48 hours
Title
Freedom from phonophobia
Description
Dichotomous endpoint of resolution of phonophobia
Time Frame
1 hour, 2 hours, 24 hours, 48 hours
Title
Freedom from nausea
Description
Dichotomous endpoint of resolution of nausea
Time Frame
1 hour, 2 hours, 24 hours, 48 hours
Title
Freedom from vomiting
Description
Dichotomous endpoint of whether patient vomited during this migraine attack
Time Frame
At any time over 48 hours
Title
Use of rescue medication
Description
Dichotomous endpoint of use of rescue medication
Time Frame
At any time over 48 hours
Title
Sustained pain freedom
Description
Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain
Time Frame
24 hours and 48 hours
Title
Sustained most bothersome symptom freedom
Description
Dichotomous endpoint of absence of most bothersome symptom at 2 hours afer dose, with no use of rescue medication and no relapse of most bothersome symptom
Time Frame
24 hours and 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 or past adverse effects or negative past experiences from cannabis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel M Schuster, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Pain Medicine, UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.
IPD Sharing Time Frame
Beginning 1 year and ending 5 years after article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu.

Learn more about this trial

Efficacy of Inhaled Cannabis for Acute Migraine Treatment

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