Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Headache Pain Freedom at 2 Hour Post-Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Each participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. The 4 treatments will be identically encapsulated by the study pharmacist. The study pharmacist will place the capsules in identical sealed plastic bags labeled "Migraine 1" through "Migraine 4."
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment
- •Pregnancy
- •Breastfeeding
- •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
研究组 & 干预措施
THC ~10%
Inhalation of cannabis flower containing THC ~10%
干预措施: THC ~10% (Drug)
THC ~2.5%
Inhalation of cannabis flower containing THC ~2.5%
干预措施: THC ~2.5% (Drug)
THC ~5%
Inhalation of cannabis flower containing THC ~5%
干预措施: THC ~5% (Drug)
Sham Cannabis
Inhalation of cannabis flower from which the THC and CBD have been extracted
干预措施: Sham Cannabis (Drug)
结局指标
主要结局
Headache Pain Freedom at 2 Hour Post-Treatment
时间窗: 2 Hours Post-Treatment
Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain
次要结局
- Headache Pain Relief at 2 Hours Post-Treatment(2 Hours Post-Treatment)
- Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment(2 Hours Post-Treatment)
研究者
Nathaniel Schuster
Associate Professor
University of California, San Diego