Repeat Dosing of Psilocybin in Migraine Headache

NCT ID: NCT04218539

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2023-11-05

Brief Summary

In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured.

Detailed Description

Migraine headache is a common medical condition and a top cause of disability worldwide. Treatment options for migraine headache are many and varied, though an approximated 10% of migraineurs is refractory to medication and thus, there is a need to develop alternative treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited dosing of psilocybin and related compounds in headache disorders. The cause of this unique effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a biological process relevant to migraine and other headache disorders. In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. The results from this study will serve in the development of larger investigations seeking to understand the effects of psilocybin and related compounds in headache disorders.

Conditions

Migraine Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo/Placebo

Subjects will receive a dose of placebo, followed by a dose of placebo approximately 7 days later.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

25mg Diphenhydramine

Placebo/Psilocybin

Subjects will receive a dose of placebo, followed by a dose of psilocybin approximately 7 days later.

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

10mg Psilocybin

Placebo

Intervention Type: DRUG

25mg Diphenhydramine

Psilocybin/Placebo

Subjects will receive a dose of psilocybin, followed by a dose of placebo approximately 7 days later.

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

10mg Psilocybin

Placebo

Intervention Type: DRUG

25mg Diphenhydramine

Psilocybin/Psilocybin

Subjects will receive a dose of psilocybin, followed by a dose of psilocybin approximately 7 days later.

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

10mg Psilocybin

Interventions

Psilocybin

10mg Psilocybin

Intervention Type: DRUG

Placebo

25mg Diphenhydramine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of migraine headache per ICHD-3 criteria
• Typical pattern of migraine attacks with approximately two migraines or more weekly
• Attacks are managed by means involving no more than twice weekly triptan use

Exclusion Criteria

• Axis I psychotic or manic disorder (e.g., schizophrenia, bipolar I, depression with psychosis)
• Axis I psychotic or manic 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, lysergic acid diethylamide (LSD), or related compounds
• Drug abuse within the past 3 months (excluding tobacco)
• Urine toxicology positive to drugs of abuse
• Alcohol use of >21 drinks per week (males); >14 drinks per week (females; NIAAA guidelines)
• Use of alcohol in the week prior to the first test day
• 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
• Use of migraine onabotulinum toxin (i.e., Botox) or monoclonal antibodies against CGRP or its receptor (i.e., erenumab) in the past month or while therapeutic effects are still present

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

Sponsors

The Wallace Foundation

OTHER

Sponsor Role: collaborator

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

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000026974

Identifier Type: -

Identifier Source: org_study_id