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Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment

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ClinicalTrials.gov Identifier: NCT05427630
Recruitment Status : Not yet recruiting
First Posted : June 22, 2022
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Nathaniel Schuster, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Migraine Cannabis THC Drug: THC ~2.5% Drug: THC ~5% Drug: THC ~10% Drug: Sham Cannabis Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, Double-blind, Placebo-controlled, Dose-ranging 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. The study pharmacist will place the capsules in identical sealed plastic bags labeled "Migraine 1" through "Migraine 4."
Primary Purpose: Treatment
Official Title: Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Marijuana Migraine

Arm Intervention/treatment
Experimental: THC ~2.5%
Inhalation of cannabis flower containing THC ~2.5%
Drug: THC ~2.5%
Cannabis flower containing THC ~2.5%
Other Names:
  • THC
  • delta 9-tetrahydrocannabinol
  • marijuana

Experimental: THC ~5%
Inhalation of cannabis flower containing THC ~5%
Drug: THC ~5%
Cannabis flower containing THC ~5%
Other Names:
  • THC
  • delta 9-tetrahydrocannabinol
  • marijuana

Experimental: THC ~10%
Inhalation of cannabis flower containing THC ~10%
Drug: THC ~10%
Cannabis flower containing THC ~5%
Other Names:
  • THC
  • delta 9-tetrahydrocannabinol
  • marijuana

Sham Comparator: Sham Cannabis
Inhalation of cannabis flower from which the THC and CBD have been extracted
Drug: Sham Cannabis
Cannabis flower from which the THC and CBD have been extracted
Other Names:
  • Placebo
  • Sham




Primary Outcome Measures :
  1. Headache Pain Freedom at 2 Hour Post-Treatment [ Time Frame: 2 Hours Post-Treatment ]
    Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain


Secondary Outcome Measures :
  1. Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment [ Time Frame: 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

  2. Headache Pain Relief at 2 Hours Post-Treatment [ Time Frame: 2 Hours Post-Treatment ]
    Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain


Other Outcome Measures:
  1. Headache pain freedom [ Time Frame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours ]
    Dichotomous outcome of reduction from moderate/severe to no pain

  2. Most bothersome symptom (MBS) [ Time Frame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours ]
    Dichotomous outcome of resolution of MBS (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration

  3. Headache pain relief [ Time Frame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours ]
    Dichotomous outcome of reduction from moderate/severe to mild/no pain

  4. Freedom from photophobia [ Time Frame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours ]
    Dichotomous outcome of resolution of photophobia

  5. Freedom from phonophobia [ Time Frame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours ]
    Dichotomous outcome of resolution of phonophobia

  6. Freedom from nausea [ Time Frame: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours ]
    Dichotomous outcome of resolution of nausea

  7. Freedom from vomiting [ Time Frame: At any time over 48 hours ]
    Dichotomous outcome of whether patient vomited during this migraine attack

  8. Use of rescue medication [ Time Frame: At any time over 48 hours ]
    Dichotomous outcome of use of rescue medication

  9. Sustained pain freedom [ Time Frame: 24 hours and 48 hours ]
    Dichotomous outcome of absence of headache pain at 2 hours after dose, with no use of rescue medication and no recurrence of headache pain

  10. Sustained most bothersome symptom freedom (MBS) [ Time Frame: 24 hours and 48 hours ]
    Dichotomous outcome of absence of MBS at 2 hours after dose, with no use of rescue medication and no recurrence of MBS



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427630


Contacts
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Contact: Phirum Nguyen 858-822-3108 psnguyen@health.ucsd.edu
Contact: Gayle Dizon 858-822-3108 gdizon@health.ucsd.edu

Locations
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United States, California
Center for Pain Medicine, UC San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Nathaniel M Schuster, MD Center for Pain Medicine, UC San Diego
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Responsible Party: Nathaniel Schuster, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05427630    
Other Study ID Numbers: 802999
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nathaniel Schuster, University of California, San Diego:
Migraine
Cannabis
THC
Additional relevant MeSH terms:
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Migraine Disorders
Marijuana Abuse
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists