Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in intensity of phonophobia
研究概览
简要总结
The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.
详细描述
The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.
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
- Double (Participant, Care Provider)
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-3beta 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
- •Age 21 to 65
排除标准
- •Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- •Axis I psychotic 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, LSD, or related compounds
- •Drug or alcohol abuse within the past 3 months (excluding tobacco)
- •Urine toxicology positive to drugs of abuse
- •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
研究组 & 干预措施
Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
干预措施: Low Dose Psilocybin (Drug)
Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
干预措施: Placebo (Drug)
Placebo/High Dose Psilocybin
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
干预措施: High Dose Psilocybin (Drug)
Placebo/High Dose Psilocybin
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
干预措施: Placebo (Drug)
Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
干预措施: Low Dose Psilocybin (Drug)
Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
干预措施: Placebo (Drug)
High Dose Psilocybin/Placebo
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
干预措施: High Dose Psilocybin (Drug)
High Dose Psilocybin/Placebo
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in intensity of phonophobia
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in migraine attack frequency
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average number (number per week)
Change in migraine attack duration
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average duration (measured in hours)
Change in intensity of nausea/vomiting during migraine attacks
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in migraine headache days
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average days (number of days per week)
Change in pain intensity of migraine attacks
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in intensity of photophobia
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in migraine attack-related functional disability
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
次要结局
- Change in the use of abortive/rescue medication(From two weeks before first session to two weeks 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 first session to three months after second session using a headache diary)
- Change in blood pressure(Measured during each test session prior to drug administration, every 15 minutes in the first hour, every 30 minutes in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug))
- Time to first migraine attack(From the day of each session until two weeks after each test session)
- Change in heart rate(Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug))
- Time to second migraine attack(From the day of each session until two weeks after each test session)
- Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale(Taken on each test day approximately 6 hours after drug administration)
- Change in peripheral oxygenation(Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug))