search
Back to results

Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

Primary Purpose

Migraine, Cannabis, THC

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
THC ~2.5%
THC ~5%
THC ~10%
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

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 4.5 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 to 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 ~2.5%

THC ~5%

THC ~10%

Sham Cannabis

Arm Description

Inhalation of cannabis flower containing THC ~2.5%

Inhalation of cannabis flower containing THC ~5%

Inhalation of cannabis flower containing THC ~10%

Inhalation of cannabis flower from which the THC and CBD have been extracted

Outcomes

Primary Outcome Measures

Headache Pain Freedom at 2 Hour Post-Treatment
Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2022
Last Updated
February 15, 2023
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT05427630
Brief Title
Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
Official Title
Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

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

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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomized, Double-blind, Placebo-controlled, Dose-ranging 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. The study pharmacist will place the capsules in identical sealed plastic bags labeled "Migraine 1" through "Migraine 4."
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
THC ~2.5%
Arm Type
Experimental
Arm Description
Inhalation of cannabis flower containing THC ~2.5%
Arm Title
THC ~5%
Arm Type
Experimental
Arm Description
Inhalation of cannabis flower containing THC ~5%
Arm Title
THC ~10%
Arm Type
Experimental
Arm Description
Inhalation of cannabis flower containing THC ~10%
Arm Title
Sham Cannabis
Arm Type
Sham Comparator
Arm Description
Inhalation of cannabis flower from which the THC and CBD have been extracted
Intervention Type
Drug
Intervention Name(s)
THC ~2.5%
Other Intervention Name(s)
THC, delta 9-tetrahydrocannabinol, marijuana
Intervention Description
Cannabis flower containing THC ~2.5%
Intervention Type
Drug
Intervention Name(s)
THC ~5%
Other Intervention Name(s)
THC, delta 9-tetrahydrocannabinol, marijuana
Intervention Description
Cannabis flower containing THC ~5%
Intervention Type
Drug
Intervention Name(s)
THC ~10%
Other Intervention Name(s)
THC, delta 9-tetrahydrocannabinol, marijuana
Intervention Description
Cannabis flower containing THC ~5%
Intervention Type
Drug
Intervention Name(s)
Sham Cannabis
Other Intervention Name(s)
Placebo, Sham
Intervention Description
Cannabis flower from which the THC and CBD have been extracted
Primary Outcome Measure Information:
Title
Headache Pain Freedom at 2 Hour Post-Treatment
Description
Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain
Time Frame
2 Hours Post-Treatment
Secondary Outcome Measure Information:
Title
Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment
Description
Dichotomous outcome of resolution of most bothersome symptom (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration
Time Frame
2 Hours Post-Treatment
Title
Headache Pain Relief at 2 Hours Post-Treatment
Description
Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Time Frame
2 Hours Post-Treatment
Other Pre-specified Outcome Measures:
Title
Headache pain freedom
Description
Dichotomous outcome of reduction from moderate/severe to no pain
Time Frame
15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Title
Most bothersome symptom (MBS)
Description
Dichotomous outcome of resolution of MBS (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration
Time Frame
15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Title
Headache pain relief
Description
Dichotomous outcome of reduction from moderate/severe to mild/no pain
Time Frame
15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Title
Freedom from photophobia
Description
Dichotomous outcome of resolution of photophobia
Time Frame
15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Title
Freedom from phonophobia
Description
Dichotomous outcome of resolution of phonophobia
Time Frame
15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Title
Freedom from nausea
Description
Dichotomous outcome of resolution of nausea
Time Frame
15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Title
Freedom from vomiting
Description
Dichotomous outcome of whether patient vomited during this migraine attack
Time Frame
At any time over 48 hours
Title
Use of rescue medication
Description
Dichotomous outcome of use of rescue medication
Time Frame
At any time over 48 hours
Title
Sustained pain freedom
Description
Dichotomous outcome of absence of headache pain at 2 hours after dose, with no use of rescue medication and no recurrence of headache pain
Time Frame
24 hours and 48 hours
Title
Sustained most bothersome symptom freedom (MBS)
Description
Dichotomous outcome of absence of MBS at 2 hours after dose, with no use of rescue medication and no recurrence of MBS
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 4.5 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 to cannabis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel M Schuster, MD
Organizational Affiliation
Center for Pain Medicine, UC 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

Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

We'll reach out to this number within 24 hrs