A Phase 1 interventional study of High Dose Psilocybin and Low Dose Psilocybin in Migraine 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 2023-10-12.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.
The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.
Exclusion Criteria:
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Drug: Low Dose Psilocybin · Drug: Placebo
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
Drug: High Dose Psilocybin · Drug: Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Drug: Low Dose Psilocybin · Drug: Placebo
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
Drug: High Dose Psilocybin · Drug: Placebo
0.143 mg/kg psilocybin capsule
0.0143 mg/kg psilocybin capsule
microcrystalline cellulose capsule
Change in migraine headache days
Average days (number of days per week)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in migraine attack frequency
Average number (number per week)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in migraine attack duration
Average duration (measured in hours)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in pain intensity of migraine attacks
Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of nausea/vomiting during migraine attacks
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of photophobia
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of phonophobia
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in migraine attack-related functional disability
Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Change in the use of abortive/rescue medication
number of days (number of days per week using a migraine abortive)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Time to first migraine attack
Measured in days
Time frame: From the day of each session until two weeks after each test session
Time to second migraine attack
Measured in days
Time frame: From the day of each session until two weeks after each test session
Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module
4 questions scored 0 to 30 each; higher numbers indicate worse quality of life. (1) pain-related impairment, (2) mood symptoms, (3) anxiety symptoms, and (4) lack of sleep Percent change for each measure as well as total score (range 0 to 120) will be calculated.
Time frame: From two weeks before first session to three months after second session using a headache diary
Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale
94 questions scored 0 to 100 each; higher numbers indicate greater psychedelic effects Questions address 5 dimensions: (1) Oceanic boundlessness (score range 0-2700), (2) Dread of Ego Dissolution (score range 0-2100), (3) Visionary Restructuralization (score range 0-1800), (4) Auditory Alterations (score range 0-1600), and (5) Vigilance reduction (score range 0-1200) Score for each dimension as well as total score (range 0 to 9400) will be measured.
Time frame: Taken on each test day approximately 6 hours after drug administration
Change in blood pressure
Maximum change in mean arterial blood pressure from baseline during each test day (mmHg)
Time frame: Measured during each test session prior to drug administration, every 15 minutes in the first hour, every 30 minutes 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 test day (beats per minute)
Time frame: Measured during each test session prior to drug administration, every 15 min in the first hour, 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 test day (SpO2)
Time frame: Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)
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Yale University