Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2016-12-05
2022-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Psilocybin High Dose
0.143 mg/kg Psilocybin or 10 mg Psilocybin
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)
Psilocybin Low Dose
0.0143 mg/kg Psilocybin or 1 mg Psilocybin
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)
Placebo
Placebo
Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)
Interventions
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0.143 mg/kg Psilocybin or 10 mg Psilocybin
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 or 1 mg Psilocybin
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)
Placebo
Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
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Heffter Research Institute
OTHER
Ceruvia Lifesciences
UNKNOWN
CH TAC LLC
UNKNOWN
Yale University
OTHER
Responsible Party
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Deepak C. D'Souza
Professor of Psychiatry
Locations
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VA Connecticut Healthcare System
West Haven, Connecticut, United States
Countries
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References
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Schindler EAD, Sewell RA, Gottschalk CH, Flynn LT, Zhu Y, Pittman BP, Cozzi NV, D'Souza DC. Psilocybin pulse regimen reduces cluster headache attack frequency in the blinded extension phase of a randomized controlled trial. J Neurol Sci. 2024 May 15;460:122993. doi: 10.1016/j.jns.2024.122993. Epub 2024 Apr 2.
Other Identifiers
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1607018057
Identifier Type: -
Identifier Source: org_study_id