Effects of Psilocybin in Concussion Headache

Yale University

Status and phase: Terminated; Phase 1

Conditions: Post-Traumatic Headache

Treatments: Drug: Placebo oral capsule; Drug: High Dose Psilocybin; Drug: Low Dose Psilocybin

Study type: Interventional

Funder types: Other

Identifiers

NCT03806985

1607018057.B

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

12 participants in 6 patient groups

Placebo/Low Dose Psilocybin

Experimental group

Description:

Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.

Treatment:

Drug: Low Dose Psilocybin

Drug: Placebo oral capsule

Placebo/High Dose Psilocybin

Experimental group

Description:

Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.

Treatment:

Drug: Placebo oral capsule

Drug: High Dose Psilocybin

Low Dose Psilocybin/Placebo

Experimental group

Description:

Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.

Treatment:

Drug: Low Dose Psilocybin

Drug: Placebo oral capsule

High Dose Psilocybin/Placebo

Experimental group

Description:

Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.

Treatment:

Drug: Placebo oral capsule

Drug: High Dose Psilocybin

High Dose Psilocybin/Low Dose Psilocybin

Experimental group

Description:

Subjects in this arm receive high dose psilocybin in the first session and low dose psilocybin in the second session.

Treatment:

Drug: Low Dose Psilocybin

Drug: High Dose Psilocybin

Low Dose Psilocybin/High Dose Psilocybin

Experimental group

Description:

Subjects in this arm receive low dose psilocybin in the first session and high dose psilocybin in the second session.

Treatment:

Drug: Low Dose Psilocybin

Drug: High Dose Psilocybin