Effects of Psilocybin in Concussion Headache

NCT ID: NCT03806985

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2023-06-27

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.

Conditions

Post-Traumatic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo/Low Dose Psilocybin

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

Group Type: EXPERIMENTAL

Placebo oral capsule

Intervention Type: DRUG

microcrystalline cellulose capsule

Low Dose Psilocybin

Intervention Type: DRUG

0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)

Placebo/High Dose Psilocybin

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

Group Type: EXPERIMENTAL

Placebo oral capsule

Intervention Type: DRUG

microcrystalline cellulose capsule

High Dose Psilocybin

Intervention Type: DRUG

0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)

Low Dose Psilocybin/Placebo

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

Group Type: EXPERIMENTAL

Placebo oral capsule

Intervention Type: DRUG

microcrystalline cellulose capsule

Low Dose Psilocybin

Intervention Type: DRUG

0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)

High Dose Psilocybin/Placebo

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

Group Type: EXPERIMENTAL

Placebo oral capsule

Intervention Type: DRUG

microcrystalline cellulose capsule

High Dose Psilocybin

Intervention Type: DRUG

0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)

High Dose Psilocybin/Low Dose Psilocybin

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

Group Type: EXPERIMENTAL

Low Dose Psilocybin

Intervention Type: DRUG

0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)

High Dose Psilocybin

Intervention Type: DRUG

0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)

Low Dose Psilocybin/High Dose Psilocybin

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

Group Type: EXPERIMENTAL

Low Dose Psilocybin

Intervention Type: DRUG

0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)

High Dose Psilocybin

Intervention Type: DRUG

0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)

Interventions

Placebo oral capsule

microcrystalline cellulose capsule

Intervention Type: DRUG

Low Dose Psilocybin

0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)

Intervention Type: DRUG

High Dose Psilocybin

0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1607018057.B

Identifier Type: -

Identifier Source: org_study_id