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| Name | Class |
|---|---|
| Ceruvia Lifesciences | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Low Dose Psilocybin | Experimental | Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session. |
|
| Placebo/High Dose Psilocybin | Experimental | Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session. |
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| Low Dose Psilocybin/Placebo | Experimental | Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session. |
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| High Dose Psilocybin/Placebo | Experimental | Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Psilocybin | Drug | 0.143 mg/kg psilocybin capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in migraine headache days | Average days (number of days per week) | 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) | 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) | 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) | 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) | 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) | From two weeks before first session to two weeks after second session using a headache diary |
| Change in intensity of phonophobia |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the use of abortive/rescue medication | number of days (number of days per week using a migraine abortive) | From two weeks before first session to two weeks after second session using a headache diary |
| Time to first migraine attack |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System, West Haven Campus | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33184743 | Derived | Schindler EAD, Sewell RA, Gottschalk CH, Luddy C, Flynn LT, Lindsey H, Pittman BP, Cozzi NV, D'Souza DC. Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin. Neurotherapeutics. 2021 Jan;18(1):534-543. doi: 10.1007/s13311-020-00962-y. Epub 2020 Nov 12. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Low Dose Psilocybin | Drug | 0.0143 mg/kg psilocybin capsule |
|
| Placebo | Drug | microcrystalline cellulose capsule |
|
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
| 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) | From two weeks before first session to two weeks after second session using a headache diary |
Measured in days
| From the day of each session until two weeks after each test session |
| Time to second migraine attack | Measured in days | 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. | 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. | 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) | 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) | 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) | 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) |
| D009422 | Nervous System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |