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Efficacy of Inhaled Cannabis for Acute Migraine Treatment

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ClinicalTrials.gov Identifier: NCT04360044
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
Migraine Research Foundation
Information provided by (Responsible Party):
Nathaniel Schuster, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE April 21, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE November 20, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
Headache Pain Relief at 2 Hours Post-Treatment [ Time Frame: 2 Hours Post-Treatment ]
Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • Headache pain freedom [ Time Frame: 2 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to no pain
  • Most bothersome symptom freedom [ Time Frame: 2 hours ]
    Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 16, 2021)
  • Headache pain relief [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain
  • Headache pain freedom [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to no pain
  • Most bothersome symptom freedom [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
  • Freedom from photophobia [ Time Frame: 1 hour, 2 hours, 24 hours, 48 hours ]
    Dichotomous endpoint of resolution of photophobia
  • Freedom from phonophobia [ Time Frame: 1 hour, 2 hours, 24 hours, 48 hours ]
    Dichotomous endpoint of resolution of phonophobia
  • Freedom from nausea [ Time Frame: 1 hour, 2 hours, 24 hours, 48 hours ]
    Dichotomous endpoint of resolution of nausea
  • Freedom from vomiting [ Time Frame: At any time over 48 hours ]
    Dichotomous endpoint of whether patient vomited during this migraine attack
  • Use of rescue medication [ Time Frame: At any time over 48 hours ]
    Dichotomous endpoint of use of rescue medication
  • Sustained pain freedom [ Time Frame: 24 hours and 48 hours ]
    Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain
  • Sustained most bothersome symptom freedom [ Time Frame: 24 hours and 48 hours ]
    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
Original Other Pre-specified Outcome Measures
 (submitted: April 21, 2020)
  • Headache pain relief [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain
  • Headache pain freedom [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to no pain
  • Most bothersome symptom freedom [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration
  • Freedom from photophobia [ Time Frame: 1 hour and 2 hours ]
    Dichotomous endpoint of resolution of photophobia
  • Freedom from phonophobia [ Time Frame: 1 hour and 2 hours ]
    Dichotomous endpoint of resolution of phonophobia
  • Use of rescue medication [ Time Frame: At any time over 48 hours ]
    Dichotomous endpoint of use of rescue medication
  • Sustained pain freedom [ Time Frame: 24 hours and 48 hours ]
    Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain
  • Sustained most bothersome symptom freedom [ Time Frame: 24 hours and 48 hours ]
    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
 
Descriptive Information
Brief Title  ICMJE Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Official Title  ICMJE Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized, Double-blind, Placebo-controlled, Crossover Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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."
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine
  • Cannabis
  • THC
  • CBD
Intervention  ICMJE
  • Drug: THC ~5%
    4 puffs of vaporized flower containing THC ~5%
    Other Names:
    • THC
    • delta 9-tetrahydrocannabinol
    • marijuana
  • Drug: CBD ~12%
    4 puffs of vaporized flower containing CBD ~12%
    Other Names:
    • CBD
    • cannabidiol
    • hemp
  • Drug: THC ~5% and CBD ~12%
    4 puffs of vaporized flower containing THC ~5% and CBD ~12%
    Other Names:
    • THC
    • CBD
    • delta 9-tetrahydrocannabinol
    • cannabidiol
    • marijuana
    • hemp
  • Drug: Sham Cannabis
    4 puffs of vaporized flower from which the THC and CBD have been extracted
    Other Names:
    • Placebo
    • Sham
Study Arms  ICMJE
  • Experimental: THC ~5%
    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).
    Intervention: Drug: THC ~5%
  • Experimental: THC ~5%/CBD ~12%
    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).
    Intervention: Drug: THC ~5% and CBD ~12%
  • Experimental: CBD ~12%
    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).
    Intervention: Drug: CBD ~12%
  • Sham Comparator: Sham Cannabis
    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: Drug: Sham Cannabis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Phirum Ngyuen 858-822-3108 psnguyen@health.ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04360044
Other Study ID Numbers  ICMJE 2018 MRF Impact Award
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 1 year and ending 5 years after article publication
Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu.
Responsible Party Nathaniel Schuster, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Migraine Research Foundation
Investigators  ICMJE
Principal Investigator: Nathaniel M Schuster, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP