A Phase 1 interventional study of Placebo oral capsule and Low Dose Psilocybin in Post-Traumatic Headache, sponsored by Yale University. Terminated 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 post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. 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. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.
194 studies on the registry are indexed under Post-Traumatic Headache; 51 are open to participants now.
This study's enrollment of 12 is below the median of 44 across 170 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
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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:
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Drug: Placebo oral capsule · Drug: Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
Drug: Placebo oral capsule · Drug: High Dose Psilocybin
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Drug: Placebo oral capsule · Drug: Low Dose Psilocybin
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
Drug: Placebo oral capsule · Drug: High Dose Psilocybin
Subjects in this arm receive high dose psilocybin in the first session and low dose psilocybin in the second session.
Drug: Low Dose Psilocybin · Drug: High Dose Psilocybin
Subjects in this arm receive low dose psilocybin in the first session and high dose psilocybin in the second session.
Drug: Low Dose Psilocybin · Drug: High Dose Psilocybin
microcrystalline cellulose capsule
0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)
0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)
Acute change in pain intensity
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in nausea/vomiting
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in photophobia
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in phonophobia
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in functional disability
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration
Time to first headache attack
Measured in days
Time frame: Two weeks following each test session
Time to last headache attack
Measured in days
Time frame: Two weeks following each test session
Change in headache 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 headache 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 headache 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 headache attacks
Average intensity of nausea/vomiting (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 during headache attacks
Average intensity of photophobia (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 during headache attacks
Average intensity of phonophobia (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 functional disability during headache attacks
Average intensity of functional 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
Use of abortive/rescue medication
number of times per week
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Headache attack-free time
Number of 24 hour days (may be non-consecutive)
Time frame: From two weeks before first session to two weeks after second session using a headache diary
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 two weeks after second session using a headache diary
Depression using Patient Health Questionnaire 9 (PHQ-9)
9 question self-report questionnaire to assess the presence of depression-related symptoms. Each question is rated on a scale of 0-3 (0 = Not at all; 1 = Several days; 2 = More than half the days; 3 = Nearly every day). Higher scores indicate greater presence of depression-related symptoms. Total score is calculated. Total score 5-9 = minimal symptoms; total score 10-14 = Major Depression, mild; total score 15-19 = Major Depression, moderately severe; total score \>20 = Major Depression severe.
Time frame: From two weeks before first session to two weeks after second session using a headache diary
Suicide risk using the Columbia Suicide Severity Rating Scale (CSSRS)
A 10-category assessment of suicidal ideation and behavior. 5 categories (scored "yes/no") relate to the presence of suicidal ideation. 5 categories (scored "yes/no") relate to the presence of suicidal behavior. A "yes" to any of the suicidal ideation categories indicates the presence of suicidal ideation; a "yes" to any of the suicidal behavior categories indicates the presence of suicidal behavior.
Time frame: From two weeks before first session to two weeks 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 from baseline during each test day (mmHg)
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 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)
Change in peripheral levels of calcitonin gene-related peptide (CGRP)
Change from baseline during each test day (pg/mg protein)
Time frame: Measured during each test session prior to drug administration, and at 2 and 4 hours after drug administration
Change in peripheral levels of pituitary adenylate cyclase-activating peptide (PACAP)
Change from baseline during each test day (pg/mg protein)
Time frame: Measured during each test session prior to drug administration, and at 2 and 4 hours after drug administration
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Psilocybin