Abstract：
BACKGROUND: In a recent randomized, double-blind, placebo-controlled study, we observed a nonsignificant reduction of attack frequency in cluster headache after pulse administration of psilocybin (10 mg/70 kg, 3 doses, 5 days apart each). We carried out a blinded extension phase to consider the safety and efficacy of repeating the pulse regimen.
METHODS: Eligible participants returned to receive a psilocybin pulse at least 6 months after their first round of study participation. Participants kept headache diaries starting two weeks before and continuing through eight weeks after the first drug session. Ten participants completed the extension phase and all ten were included in the final analysis.
RESULTS: In the three weeks after the start of the pulse, cluster attack frequency was significantly reduced from baseline (18.4 [95% confidence interval 8.4 to 28.4] to 9.8 [4.3 to 15.2] attacks/week; p = 0.013, d\' = 0.97). A reduction of approximately 50% was seen regardless of individual response to psilocybin in the first round. Psilocybin was well-tolerated without any unexpected or serious adverse events.
CONCLUSIONS: This study shows a significant reduction in cluster attack frequency in a repeat round of pulse psilocybin administration and suggests that prior response may not predict the effect of repeated treatment. To gauge the full potential of psilocybin as a viable medicine in cluster headache, future work should investigate the safety and therapeutic efficacy in larger, more representative samples over a longer time period, including repeating the treatment.
BACKGROUND: NCT02981173.
METHODS: Eligible participants returned to receive a psilocybin pulse at least 6 months after their first round of study participation. Participants kept headache diaries starting two weeks before and continuing through eight weeks after the first drug session. Ten participants completed the extension phase and all ten were included in the final analysis.
RESULTS: In the three weeks after the start of the pulse, cluster attack frequency was significantly reduced from baseline (18.4 [95% confidence interval 8.4 to 28.4] to 9.8 [4.3 to 15.2] attacks/week; p = 0.013, d\' = 0.97). A reduction of approximately 50% was seen regardless of individual response to psilocybin in the first round. Psilocybin was well-tolerated without any unexpected or serious adverse events.
CONCLUSIONS: This study shows a significant reduction in cluster attack frequency in a repeat round of pulse psilocybin administration and suggests that prior response may not predict the effect of repeated treatment. To gauge the full potential of psilocybin as a viable medicine in cluster headache, future work should investigate the safety and therapeutic efficacy in larger, more representative samples over a longer time period, including repeating the treatment.
BACKGROUND: NCT02981173.
摘要：
背景：在最近的一项随机研究中，双盲,安慰剂对照研究，我们观察到脉冲给药后，丛集性头痛的发作频率没有显着降低（10mg/70kg，3剂,每个间隔5天）。我们进行了盲延伸阶段，以考虑重复脉冲方案的安全性和有效性。
方法：符合条件的参与者在第一轮研究参与后至少6个月返回接受psilocybin脉冲。参与者在第一次服药前两周开始记录头痛日记，并在第一次服药后持续八周。十名参与者完成了扩展阶段，所有十名都包括在最终分析中。
结果：在脉搏开始后的三周内，集群攻击频率较基线显著降低(18.4[95%置信区间8.4~28.4]至9.8[4.3~15.2]次攻击/周;p=0.013,d'=0.97).观察到约50%的减少,无论在第一轮中个体对裸盖素的反应如何。Psilocybin耐受性良好，没有任何意外或严重的不良事件。
结论：本研究显示，在反复循环脉冲裸盖素给药过程中，集群攻击频率显著降低，并提示先前的反应可能无法预测反复治疗的效果。为了评估psilocybin作为丛集性头痛的可行药物的全部潜力，未来的工作应该研究更大的安全性和治疗效果，在更长的时间内更有代表性的样本，包括重复治疗。
背景：NCT02981173。
方法：符合条件的参与者在第一轮研究参与后至少6个月返回接受psilocybin脉冲。参与者在第一次服药前两周开始记录头痛日记，并在第一次服药后持续八周。十名参与者完成了扩展阶段，所有十名都包括在最终分析中。
结果：在脉搏开始后的三周内，集群攻击频率较基线显著降低(18.4[95%置信区间8.4~28.4]至9.8[4.3~15.2]次攻击/周;p=0.013,d'=0.97).观察到约50%的减少,无论在第一轮中个体对裸盖素的反应如何。Psilocybin耐受性良好，没有任何意外或严重的不良事件。
结论：本研究显示，在反复循环脉冲裸盖素给药过程中，集群攻击频率显著降低，并提示先前的反应可能无法预测反复治疗的效果。为了评估psilocybin作为丛集性头痛的可行药物的全部潜力，未来的工作应该研究更大的安全性和治疗效果，在更长的时间内更有代表性的样本，包括重复治疗。
背景：NCT02981173。
