Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Acute change in nausea/vomiting
研究概览
简要总结
The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. 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. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.
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 post-traumatic headache
- •Typical pattern of headache attacks with approximately two attacks or more weekly
- •Attacks are managed by means involving no more than twice weekly triptan use
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: Placebo oral capsule (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: Low 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 oral capsule (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)
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 oral capsule (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)
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 oral capsule (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/Low Dose Psilocybin
Subjects in this arm receive high dose psilocybin in the first session and low dose psilocybin in the second session.
干预措施: Low Dose Psilocybin (Drug)
High Dose Psilocybin/Low Dose Psilocybin
Subjects in this arm receive high dose psilocybin in the first session and low dose psilocybin in the second session.
干预措施: High Dose Psilocybin (Drug)
Low Dose Psilocybin/High Dose Psilocybin
Subjects in this arm receive low dose psilocybin in the first session and high dose psilocybin in the second session.
干预措施: Low Dose Psilocybin (Drug)
Low Dose Psilocybin/High Dose Psilocybin
Subjects in this arm receive low dose psilocybin in the first session and high dose psilocybin in the second session.
干预措施: High Dose Psilocybin (Drug)
结局指标
主要结局
Acute change in nausea/vomiting
时间窗: Measured at 0, 1, 2, 4, and 24 hours after drug administration
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Acute change in photophobia
时间窗: Measured at 0, 1, 2, 4, and 24 hours after drug administration
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Change in intensity of photophobia during headache attacks
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average intensity of photophobia (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Change in intensity of functional disability during headache attacks
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average intensity of functional disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Acute change in pain intensity
时间窗: Measured at 0, 1, 2, 4, and 24 hours after drug administration
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Time to last headache attack
时间窗: Two weeks following each test session
Measured in days
Change in headache 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 headache attacks
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average intensity of nausea/vomiting (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Acute change in phonophobia
时间窗: Measured at 0, 1, 2, 4, and 24 hours after drug administration
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Acute change in functional disability
时间窗: Measured at 0, 1, 2, 4, and 24 hours after drug administration
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Time to first headache attack
时间窗: Two weeks following each test session
Measured in days
Change in headache 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 pain intensity of headache 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 phonophobia during headache attacks
时间窗: From two weeks before first session to two weeks after second session using a headache diary
Average intensity of phonophobia (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
次要结局
- Headache attack-free time(From two weeks before first session to two weeks after second session using a headache diary)
- 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 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))
- Change in peripheral levels of pituitary adenylate cyclase-activating peptide (PACAP)(Measured during each test session prior to drug administration, and at 2 and 4 hours after drug administration)
- 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 two weeks after second session using a headache diary)
- Depression using Patient Health Questionnaire 9 (PHQ-9)(From two weeks before first session to two weeks after second session using a headache diary)
- 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))
- Suicide risk using the Columbia Suicide Severity Rating Scale (CSSRS)(From two weeks before first session to two weeks after second session using a headache diary)
- Change in blood pressure(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))
- Change in peripheral levels of calcitonin gene-related peptide (CGRP)(Measured during each test session prior to drug administration, and at 2 and 4 hours after drug administration)