Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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:
|
| Experimental: THC ~5% Inhalation of cannabis flower containing THC ~5% |
Drug: THC ~5%
Cannabis flower containing THC ~5%
Other Names:
|
| Experimental: THC ~10% Inhalation of cannabis flower containing THC ~10% |
Drug: THC ~10%
Cannabis flower containing THC ~5%
Other Names:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Headache Pain Freedom at 2 Hour Post-Treatment [2 Hours 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 [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 [2 Hours Post-Treatment]
Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain
Other Outcome Measures
- Headache pain freedom [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
- Most bothersome symptom (MBS) [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
- Headache pain relief [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
- Freedom from photophobia [15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours]
Dichotomous outcome of resolution of photophobia
- Freedom from phonophobia [15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours]
Dichotomous outcome of resolution of phonophobia
- Freedom from nausea [15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours]
Dichotomous outcome of resolution of nausea
- Freedom from vomiting [At any time over 48 hours]
Dichotomous outcome of whether patient vomited during this migraine attack
- Use of rescue medication [At any time over 48 hours]
Dichotomous outcome of use of rescue medication
- Sustained pain freedom [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
- Sustained most bothersome symptom freedom (MBS) [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
Eligibility Criteria
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
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Agrees not to use cannabis outside of the study during participation in the study
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Agrees not to use opioids or barbiturates during participation in the study
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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
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Pregnancy
-
Breastfeeding
-
Prisoner
-
Known cognitive impairment
-
Institutionalized
-
Current moderate-severe or severe depression
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Pain Medicine, UC San Diego | La Jolla | California | United States | 92037 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
- Principal Investigator: Nathaniel M Schuster, MD, Center for Pain Medicine, UC San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 802999