Repeat Dosing of Psilocybin in Headache Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in functional disability
研究概览
简要总结
In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured.
详细描述
Migraine headache is a common medical condition and a top cause of disability worldwide. Treatment options for migraine headache are many and varied, though an approximated 10% of migraineurs is refractory to medication and thus, there is a need to develop alternative treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited dosing of psilocybin and related compounds in headache disorders. The cause of this unique effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a biological process relevant to migraine and other headache disorders. In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. The results from this study will serve in the development of larger investigations seeking to understand the effects of psilocybin and related compounds in headache disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of migraine headache per ICHD-3 criteria
- •Typical pattern of migraine attacks with approximately two migraines or more weekly
- •Attacks are managed by means involving no more than twice weekly triptan use
排除标准
- •Axis I psychotic or manic disorder (e.g., schizophrenia, bipolar I, depression with psychosis)
- •Axis I psychotic or manic disorder in first degree relative
- •Unstable medical condition; severe renal, cardiac, or hepatic disease; pacemaker; or serious central nervous system pathology
- •Pregnant, breastfeeding, lack of adequate birth control
- •History of intolerance to psilocybin, lysergic acid diethylamide (LSD), or related compounds
- •Drug abuse within the past 3 months (excluding tobacco)
- •Urine toxicology positive to drugs of abuse
- •Alcohol use of >21 drinks per week (males); >14 drinks per week (females; NIAAA guidelines)
- •Use of alcohol in the week prior to the first test day
- •Use of vasoconstrictive medications (i.e., sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days
- •Use of serotonergic antiemetics (i.e., ondansetron) in the past 2 weeks
- •Use of antidepressant medication (i.e., TCA, MAOI, SSRI) in the past 6 weeks
- •Use of steroids or certain other immunomodulatory agents (i.e., azathioprine) in the past 2 weeks
- •Use of migraine onabotulinum toxin (i.e., Botox) or monoclonal antibodies against CGRP or its receptor (i.e., erenumab) in the past month or while therapeutic effects are still present
研究组 & 干预措施
Placebo/Placebo
Subjects will receive a dose of placebo, followed by a dose of placebo approximately 7 days later.
干预措施: Placebo (Drug)
Placebo/Psilocybin
Subjects will receive a dose of placebo, followed by a dose of psilocybin approximately 7 days later.
干预措施: Psilocybin (Drug)
Placebo/Psilocybin
Subjects will receive a dose of placebo, followed by a dose of psilocybin approximately 7 days later.
干预措施: Placebo (Drug)
Psilocybin/Placebo
Subjects will receive a dose of psilocybin, followed by a dose of placebo approximately 7 days later.
干预措施: Psilocybin (Drug)
Psilocybin/Placebo
Subjects will receive a dose of psilocybin, followed by a dose of placebo approximately 7 days later.
干预措施: Placebo (Drug)
Psilocybin/Psilocybin
Subjects will receive a dose of psilocybin, followed by a dose of psilocybin approximately 7 days later.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Change in functional disability
时间窗: From two weeks before the first session to two months after second session using a headache diary
Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in migraine attack frequency
时间窗: From two weeks before the first session to two months after second session using a headache diary
Average number (number per week)
Change in pain intensity of migraine attacks
时间窗: From two weeks before the first session to two months after second session using a headache diary
Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in duration of migraine attacks
时间窗: From two weeks before the first session to two months after second session using a headache diary
Average duration (measured in hours)
Change in intensity of photophobia (light sensitivity)
时间窗: From two weeks before the first session to two months after second session using a headache diary
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in intensity of phonophobia (noise sensitivity)
时间窗: From two weeks before the first session to two months after second session using a headache diary
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Average intensity of nausea/vomiting
时间窗: From two weeks before the first session to two months after second session using a headache diary
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
次要结局
- Migraine attack-free time(From two weeks before the first session to two months after second session using a headache diary)
- Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module(From two weeks before the first session to two months after second session using a headache diary)
- Time to first migraine attack(From the second session until two months after second session using a headache diary)
- Use of abortive/rescue medication(From two weeks before the first session to two months after second session using a headache diary)
- Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale(Starting on the first test day until the second test day approximately one week later; taken both test days approximately 6 hours after drug administration)
- Change in blood pressure- Systolic(Starting on the first test day until the second test day approximately one week later; measured both test sessions before drug administration, every 30 min in the first hour, then hourly for 4 hours or until resolution of drug effects (~6hrs after drug))
- Change in blood pressure- Diastolic(Starting on the first test day until the second test day approximately one week later; measured both test sessions before drug administration, every 30 min in the first hour, then hourly for 4 hours or until resolution of drug effects (~6hrs after drug))
- Change in heart rate(Starting on the first test day until the second test day approximately one week later; measured both test sessions before drug administration, every 30 min in the first hour, then hourly for 4 hours or until resolution of drug effects (~6hrs after drug))
- Change in peripheral oxygenation(Starting on the first test day until the second test day approximately one week later; measured both test sessions before drug administration, every 30 min in the first hour, then hourly for 4 hours or until resolution of drug effects (~6hrs after drug))
- Change in peripheral calcitonin gene-related peptide (CGRP) levels(Approximately 3 months; measured at screening, on both test days (0, 2, and 4 hours after drug administration), and follow-up (~2 months after second test day))
- Change in pituitary adenylate cyclase-activating peptide (PACAP) levels(Approximately 3 months; measured at screening, on both test days (0, 2, and 4 hours after drug administration), and follow-up (~2 months after second test day))