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Cannabis for Acute Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360044
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Migraine Research Foundation
Information provided by (Responsible Party):
Nathaniel Schuster, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Migraine Cannabis THC CBD Drug: THC ~4% Drug: CBD ~6% Drug: THC ~4% and CBD ~6% 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, Double-blind, Placebo-controlled, Crossover Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana Migraine

Arm Intervention/treatment
Experimental: THC ~4%
4 puffs of cannabis flower containing THC ~4% 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).
Drug: THC ~4%
4 puffs of vaporized flower containing THC ~4%
Other Names:
  • THC
  • delta 9-tetrahydrocannabinol
  • marijuana

Experimental: THC ~4%/CBD ~6%
4 puffs of cannabis flower containing THC ~4% and CBD ~6% 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).
Drug: THC ~4% and CBD ~6%
4 puffs of vaporized flower containing THC ~4% and CBD ~6%
Other Names:
  • THC
  • CBD
  • delta 9-tetrahydrocannabinol
  • cannabidiol
  • marijuana
  • hemp

Experimental: CBD ~6%
4 puffs of cannabis flower containing CBD ~6% 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).
Drug: CBD ~6%
4 puffs of vaporized flower containing CBD ~6%
Other Names:
  • CBD
  • cannabidiol
  • hemp

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).
Drug: Sham Cannabis
4 puffs of vaporized flower from which the THC and CBD have been extracted
Other Names:
  • Placebo
  • Sham




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Headache pain freedom [ Time Frame: 2 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to no pain

  2. 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


Other Outcome Measures:
  1. Headache pain relief [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain

  2. Headache pain freedom [ Time Frame: 1 hour, 24 hours, 48 hours ]
    Dichotomous endpoint of reduction from moderate/severe pain to no pain

  3. 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

  4. Freedom from photophobia [ Time Frame: 1 hour and 2 hours ]
    Dichotomous endpoint of resolution of photophobia

  5. Freedom from phonophobia [ Time Frame: 1 hour and 2 hours ]
    Dichotomous endpoint of resolution of phonophobia

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

  7. 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

  8. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 or ≤ 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
  • Prior THC-containing cannabis experience within the past two years
  • 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
  • Inability to complete 28-day headache diary
  • 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

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): NCT04360044


Contacts
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Contact: Katie K Lam, MS, RN 858-822-0787 kklam@ucsd.edu

Sponsors and Collaborators
University of California, San Diego
Migraine Research Foundation
Investigators
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Principal Investigator: Nathaniel M Schuster, MD University of California, San Diego

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Responsible Party: Nathaniel Schuster, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04360044    
Other Study ID Numbers: 2018 MRF Impact Award
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
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
CBD
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
Epidiolex
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
Anticonvulsants