Study Stopped
Challenging to recruit qualifying subjects
Effects of Psilocybin in Concussion Headache
Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2019
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedStudy Start
First participant enrolled
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2023
CompletedOctober 12, 2023
October 1, 2023
4.3 years
January 14, 2019
October 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Acute change in pain intensity
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
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)
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)
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)
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)
Measured at 0, 1, 2, 4, and 24 hours after drug administration
Time to first headache attack
Measured in days
Two weeks following each test session
Time to last headache attack
Measured in days
Two weeks following each test session
Change in headache 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 headache 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 headache 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 headache attacks
Average intensity of nausea/vomiting (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 during headache attacks
Average intensity of photophobia (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 during headache attacks
Average intensity of phonophobia (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 functional disability during headache attacks
Average intensity of functional 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
Secondary Outcomes (11)
Use of abortive/rescue medication
From two weeks before first session to two weeks after second session using a headache diary
Headache attack-free time
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
From two weeks before first session to two weeks after second session using a headache diary
Depression using Patient Health Questionnaire 9 (PHQ-9)
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)
From two weeks before first session to two weeks after second session using a headache diary
- +6 more secondary outcomes
Study Arms (6)
Placebo/Low Dose Psilocybin
EXPERIMENTALSubjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Placebo/High Dose Psilocybin
EXPERIMENTALSubjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
Low Dose Psilocybin/Placebo
EXPERIMENTALSubjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
High Dose Psilocybin/Placebo
EXPERIMENTALSubjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
High Dose Psilocybin/Low Dose Psilocybin
EXPERIMENTALSubjects in this arm receive high dose psilocybin in the first session and low dose psilocybin in the second session.
Low Dose Psilocybin/High Dose Psilocybin
EXPERIMENTALSubjects in this arm receive low dose psilocybin in the first session and high dose psilocybin in the second session.
Interventions
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)
Eligibility Criteria
You may qualify if:
- Diagnosis of post-traumatic headache
- Typical pattern of headache attacks with approximately two attacks or more weekly
- Attacks are managed by means involving no more than twice weekly triptan use
You may not qualify if:
- Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- 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, 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 5 half-lives of test days
- Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
- Use of antidepressant medication (i.e. TCA, MAOI, SSRI) in the past 6 weeks
- Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2019
First Posted
January 16, 2019
Study Start
March 28, 2019
Primary Completion
June 27, 2023
Study Completion
June 27, 2023
Last Updated
October 12, 2023
Record last verified: 2023-10