TerminatedPhase 1

Effects of Psilocybin in Concussion Headache

NCT03806985 · Yale University

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Acute change in pain intensity
Measured over Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in nausea/vomiting
Measured over Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in photophobia
Measured over Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in phonophobia
Measured over Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in functional disability
Measured over Measured at 0, 1, 2, 4, and 24 hours after drug administration
Time to first headache attack
Measured over Two weeks following each test session
Time to last headache attack
Measured over Two weeks following each test session
Change in headache attack frequency
Measured over From two weeks before first session to two weeks after second session using a headache diary
Change in headache attack duration
Measured over From two weeks before first session to two weeks after second session using a headache diary
Change in pain intensity of headache attacks
Measured over 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
Measured over From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of photophobia during headache attacks
Measured over From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of phonophobia during headache attacks
Measured over 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
Measured over From two weeks before first session to two weeks after second session using a headache diary

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Where

1 study site

Facility	City	Region	Country
VA Connecticut Healthcare System	West Haven	Connecticut	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03806985 on ClinicalTrials.gov →

Last updated in the registry 2023-10-12. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Recruiting in

Connecticut77

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