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Completed

NCT Number: NCT04360044

Efficacy of Inhaled Cannabis for Acute Migraine Treatment

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.

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Key information

Conditions

Migraine Brain Diseases CBD Cannabis Central Nervous System Diseases Chemically-Induced Disorders Headache Disorders Headache Disorders, Primary Marijuana Abuse Mental Disorders Migraine Disorders Nervous System Diseases Substance-Related Disorders THC

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Pain Medicine, UC San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THC ~5%

Drug

4 puffs of vaporized flower containing THC ~5%

Other names: THC, delta 9-tetrahydrocannabinol, marijuana

CBD ~12%

Drug

4 puffs of vaporized flower containing CBD ~12%

Other names: CBD, cannabidiol, hemp

THC ~5% and CBD ~12%

Drug

4 puffs of vaporized flower containing THC ~5% and CBD ~12%

Other names: THC, CBD, delta 9-tetrahydrocannabinol, cannabidiol, marijuana, hemp

Sham Cannabis

Drug

4 puffs of vaporized flower from which the THC and CBD have been extracted

Other names: Placebo, Sham

Primary outcomes

  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 outcomes

  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 outcomes

  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, 2 hours, 24 hours, 48 hours

    Dichotomous endpoint of resolution of photophobia

  5. Freedom from phonophobia

    Time frame: 1 hour, 2 hours, 24 hours, 48 hours

    Dichotomous endpoint of resolution of phonophobia

  6. Freedom from nausea

    Time frame: 1 hour, 2 hours, 24 hours, 48 hours

    Dichotomous endpoint of resolution of nausea

  7. Freedom from vomiting

    Time frame: At any time over 48 hours

    Dichotomous endpoint of whether patient vomited during this migraine attack

  8. Use of rescue medication

    Time frame: At any time over 48 hours

    Dichotomous endpoint of use of rescue medication

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Migraine Research Foundation

Registry information

Official study title

Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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