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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)
VA Connecticut Healthcare System
West Haven, Connecticut, United States
Time to first attack after completion of pulse regimen
Measured in days
Time frame: Two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Time to last attack after completion of pulse regimen
Measured in days
Time frame: Six months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Change in frequency of attacks
Average number of attacks (number per week)
Time frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in intensity of attacks
Average intensity of attacks (1-10 on visual analog scale)
Time frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in duration of attacks
Average duration of attacks (minutes)
Time frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in cluster period duration compared to typical cluster period (episodic subjects only)
Duration of cluster period after intervention (days)
Time frame: 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
Difference in the change in cluster attack frequency between 1st and 2nd round
Average number of attacks (number per week); only in those subjects who return for 2nd round
Time frame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
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Difference in the change in cluster attack intensity between 1st and 2nd round
Average intensity of attacks (1-10 on visual analog scale); only in those subjects who return for 2nd round
Time frame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Difference in the change in the duration of attacks between 1st and 2nd round
Average duration of attacks (minutes); only in those subjects who return for 2nd round
Time frame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Use of abortive/rescue medication
Number of times per week
Time frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Attack-free time
Number of 24 hour days (may be nonconsecutive)
Time frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Health-Related Quality of life
Using the CDC's Health-Related Quality of Life (HRQOL) scale
Time frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Psychedelic effects
Using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale
Time frame: Taken daily on each experimental day after the resolution of psychedelic effects, approximately 6 hours after drug administration
Change in blood pressure
Maximum change from baseline during each experimental session (mmHg)
Time frame: 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
Maximum change from baseline during each experimental session (beats per minute)
Time frame: 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 peripheral oxygenation
Maximum change from baseline during each experimental session (SpO2)
Time frame: 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)