Psilocybin for the Treatment of Migraine Headache

Yale University

Status and phase: Completed; Phase 1

Conditions: Migraine Headache

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03341689

1607018057.A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 4 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

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

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

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

Drug: High Dose Psilocybin