Psilocybin for the Treatment of Migraine Headache

NCT ID: NCT03341689

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-10-31

Brief Summary

The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. 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. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.

Detailed Description

The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.

Conditions

Migraine 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

Low Dose Psilocybin

Intervention Type: DRUG

0.0143 mg/kg psilocybin capsule

Placebo

Intervention Type: DRUG

microcrystalline cellulose capsule

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

High Dose Psilocybin

Intervention Type: DRUG

0.143 mg/kg psilocybin capsule

Placebo

Intervention Type: DRUG

microcrystalline cellulose capsule

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

Low Dose Psilocybin

Intervention Type: DRUG

0.0143 mg/kg psilocybin capsule

Placebo

Intervention Type: DRUG

microcrystalline cellulose capsule

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

High Dose Psilocybin

Intervention Type: DRUG

0.143 mg/kg psilocybin capsule

Placebo

Intervention Type: DRUG

microcrystalline cellulose capsule

Interventions

High Dose Psilocybin

0.143 mg/kg psilocybin capsule

Intervention Type: DRUG

Low Dose Psilocybin

0.0143 mg/kg psilocybin capsule

Intervention Type: DRUG

Placebo

microcrystalline cellulose capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of migraine headache per ICHD-3beta 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
• Age 21 to 65

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

Ceruvia Lifesciences

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Deepak C. D'Souza

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA Connecticut Healthcare System, West Haven Campus

West Haven, Connecticut, United States

Countries

United States

References

Schindler EAD, Sewell RA, Gottschalk CH, Luddy C, Flynn LT, Lindsey H, Pittman BP, Cozzi NV, D'Souza DC. Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin. Neurotherapeutics. 2021 Jan;18(1):534-543. doi: 10.1007/s13311-020-00962-y. Epub 2020 Nov 12.

Reference Type: DERIVED

PMID: 33184743 (View on PubMed)

Other Identifiers

1607018057.A

Identifier Type: -

Identifier Source: org_study_id