Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment (NCT05427630) | Clinical Trial Compass
SuspendedPhase 2
Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
Stopped: Inadequate funding
United States20 participantsStarted 2023-02-15
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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