A Phase 1 interventional study of 0.143 mg/kg Psilocybin or 10 mg Psilocybin and 0.0143 mg/kg Psilocybin or 1 mg Psilocybin in Cluster Headache, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's enrollment of 25 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 0.143 mg/kg Psilocybin or 10 mg Psilocybin
Drug: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin
Drug: Placebo
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)
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
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)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.