Migraine Clinical Trial
Official title:
Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
Verified date | April 2024 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 20 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Center for Pain Medicine, UC San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Headache pain freedom | Dichotomous outcome of reduction from moderate/severe to no pain | 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours | |
Other | Most bothersome symptom (MBS) | Dichotomous outcome of resolution of MBS (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration | 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours | |
Other | Headache pain relief | Dichotomous outcome of reduction from moderate/severe to mild/no pain | 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours | |
Other | Freedom from photophobia | Dichotomous outcome of resolution of photophobia | 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours | |
Other | Freedom from phonophobia | Dichotomous outcome of resolution of phonophobia | 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours | |
Other | Freedom from nausea | Dichotomous outcome of resolution of nausea | 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours | |
Other | Freedom from vomiting | Dichotomous outcome of whether patient vomited during this migraine attack | At any time over 48 hours | |
Other | Use of rescue medication | Dichotomous outcome of use of rescue medication | At any time over 48 hours | |
Other | Sustained pain freedom | Dichotomous outcome of absence of headache pain at 2 hours after dose, with no use of rescue medication and no recurrence of headache pain | 24 hours and 48 hours | |
Other | Sustained most bothersome symptom freedom (MBS) | Dichotomous outcome of absence of MBS at 2 hours after dose, with no use of rescue medication and no recurrence of MBS | 24 hours and 48 hours | |
Primary | Headache Pain Freedom at 2 Hour Post-Treatment | Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain | 2 Hours Post-Treatment | |
Secondary | Most Bothersome Symptom (MBS) Freedom at 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 Hours Post-Treatment | |
Secondary | Headache Pain Relief at 2 Hours Post-Treatment | Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain | 2 Hours Post-Treatment |
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