Mechanistic Studies of Psilocybin in Headache Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in SV2A PET after drug administration
研究概览
简要总结
In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 to 70 (inclusive)
- •Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient
- •Exclusion criterion
- •Unstable medical condition or serious nervous system pathology
- •Pregnant, breastfeeding, lack of adequate birth control
- •Psychotic or manic disorder
- •Substance abuse in the prior 3 months
- •Use of classic psychedelics (e.g., psilocybin, LSD, mescaline) in the past 6 months
- •Use of cannabis or other THC products in the prior 2 weeks
- •Urine toxicology positive to drugs of abuse
- •The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average
- •Use of serotonergic preventive therapies (i.e., taken chronically; amitriptyline, fluoxetine, imipramine, cyproheptadine) in the past 6 weeks
- •Use of preventive or transitional treatments that produce spikes and waning of symptom relief (e.g., botulinum toxin, calcitonin gene-related peptide system targeting antibodies, peripheral nerve or ganglion blocks, chiropractic manipulation)
- •History of a bleeding disorder or are currently taking anticoagulants (e.g., warfarin, enoxaparin, dabigatran, apixaban).
- •Use of non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen) in the 7 days before PET scan and 7 days after PET scan.
排除标准
- 未提供
研究组 & 干预措施
Migraine psilocybin
Migraine participants randomized to receive 10 mg psilocybin (oral)
干预措施: Psilocybin (Drug)
Healthy control psilocybin
Healthy control participants randomized to receive 10 mg psilocybin (oral)
干预措施: Psilocybin (Drug)
Migraine placebo
Migraine participants randomized to receive 2.5 mg THC (oral)
干预措施: Placebo (Drug)
Healthy control placebo
Healthy control participants randomized to receive 2.5 mg THC
干预措施: Placebo (Drug)
结局指标
主要结局
Change in SV2A PET after drug administration
时间窗: from date of first PET scan to the date of second PET scan, assessed up to 6 months
Comparing change in SV2A PET after drug between psilocybin/THC and migraine/HC
Change in resting state functional connectivity (RSFC) after drug administration
时间窗: from date of first MRI to the date of second MRI, assessed up to 6 months
Comparing change in RSFC after drug between psilocybin/THC and migraine/HC
Baseline SV2A PET
时间窗: from date of randomization until the date of first PET scan, assessed up to 6 months
Comparing initial SV2A PET between migraine and HC
Baseline RSFC
时间窗: from date of randomization until the date of first MRI, assessed up to 6 months
Comparing initial RSFC between migraine and HC
次要结局
- Change in TNF-alpha(from screening to 7 days after drug administration)
- Change in IL-1beta(from screening to 7 days after drug administration)
- Change in bedtime (via actigraphy)(from screening through 14 days after drug administration)
- Change in get-up time (via actigraphy)(from screening through 14 days after drug administration)
- Change in daily active period (via actigraphy)(from screening through 14 days after drug administration)
- Change in daily rest period (via actigraphy)(from screening through 14 days after drug administration)
- Change in REM latency (via sleep electroencephalography)(from screening to 7 days after drug administration)
- Change in percent REM (via sleep electroencephalography)(from screening to 7 days after drug administration)
- Change in IL-6(from screening to 7 days after drug administration)
- Change in calcitonin gene-related peptide (CGRP)(from screening to 7 days after drug administration)
- Change in pituitary adenylate cyclase activating polypeptide (PACAP)(from screening to 7 days after drug administration)
- Adverse events(from screening through 3 months after drug administration)
- Change in sleep efficiency (via sleep electroencephalography)(from screening to 7 days after drug administration)
研究者
Emmanuelle Schindler
Assistant Professor of Neurology
Yale University