Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Time to last attack after completion of pulse regimen
研究概览
简要总结
The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Chronic cluster headache with at least one attack daily
- •Episodic cluster headache with periods that are predictable and have a duration of approximately 2 months
- •Attacks are managed by means involving no more than twice weekly triptan use (e.g., high-flow oxygen, heat/cold pack)
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, lysergic acid diethylamide (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 five half-lives of test days
- •Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
- •Use of antidepressant medications (i.e. amitriptyline, isocarboxazid, fluoxetine, citalopram) 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
干预措施: Placebo (Drug)
Psilocybin High Dose
干预措施: 0.143 mg/kg Psilocybin or 10 mg Psilocybin (Drug)
Psilocybin Low Dose
干预措施: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin (Drug)
结局指标
主要结局
Time to last attack after completion of pulse regimen
时间窗: Six months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Measured in days
Change in duration of attacks
时间窗: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Average duration of attacks (minutes)
Difference in the change in cluster attack intensity between 1st and 2nd round
时间窗: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Average intensity of attacks (1-10 on visual analog scale); only in those subjects who return for 2nd round
Difference in the change in the duration of attacks between 1st and 2nd round
时间窗: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Average duration of attacks (minutes); only in those subjects who return for 2nd round
Time to first attack after completion of pulse regimen
时间窗: Two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Measured in days
Change in cluster period duration compared to typical cluster period (episodic subjects only)
时间窗: Measured from 2 weeks before pulse regimen to 6 months following the completion of pulse regimen, then comparing to historical average duration of cluster periods
Duration of cluster period after intervention (days)
Change in frequency of attacks
时间窗: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Average number of attacks (number per week)
Change in intensity of attacks
时间窗: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Average intensity of attacks (1-10 on visual analog scale)
Difference in the change in cluster attack frequency between 1st and 2nd round
时间窗: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Average number of attacks (number per week); only in those subjects who return for 2nd round
次要结局
- Use of abortive/rescue medication(Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary)
- Attack-free time(Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary)
- Psychedelic effects(Taken daily on each experimental day after the resolution of psychedelic effects, approximately 6 hours after drug administration)
- Change in blood pressure(Measured during each experimental session prior to drug administration, every 15 min in the first hour after drug administration, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug))
- Health-Related Quality of life(Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary)
- Change in peripheral oxygenation(Measured during each experimental session prior to drug administration, every 15 min in the first hour after drug administration, 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 heart rate(Measured during each experimental session prior to drug administration, every 15 min in the first hour after drug administration, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug))
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University