Psilocybin for the Treatment of Migraine Headache

Psilocybin

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.

Intervention / Treatment

  • High Dose Psilocybin (DRUG)
    0.143 mg/kg psilocybin capsule
  • Low Dose Psilocybin (DRUG)
    0.0143 mg/kg psilocybin capsule
  • Placebo (DRUG)
    microcrystalline cellulose capsule

Condition or Disease

  • Migraine Headache

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 21 Years to 65 Years
    Enrollment: 14 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Nov 01, 2017 ACTUAL
    Primary Completion: Apr 30, 2021 ACTUAL
    Completion Date: Oct 31, 2021 ACTUAL
    Study First Posted: Nov 14, 2017 ACTUAL
    Results First Posted: Aug 30, 2020
    Last Updated: Jun 13, 2023

    Sponsors / Collaborators

    Lead Sponsor: Yale University
    Responsible Party: N/A

    Location

    West Haven, Connecticut, USA

    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.

    Participant Groups

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

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

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 21
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Average days (number of days per week)

    • Average number (number per week)

    • Average duration (measured in hours)

    • Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    • Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    • Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    • Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    • Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    Secondary Outcomes

    • number of days (number of days per week using a migraine abortive)

    • Measured in days

    • Measured in days

    • 4 questions scored 0 to 30 each; higher numbers indicate worse quality of life. (1) pain-related impairment, (2) mood symptoms, (3) anxiety symptoms, and (4) lack of sleep Percent change for each measure as well as total score (range 0 to 120) will be calculated.

    • 94 questions scored 0 to 100 each; higher numbers indicate greater psychedelic effects Questions address 5 dimensions: (1) Oceanic boundlessness (score range 0-2700), (2) Dread of Ego Dissolution (score range 0-2100), (3) Visionary Restructuralization (score range 0-1800), (4) Auditory Alterations (score range 0-1600), and (5) Vigilance reduction (score range 0-1200) Score for each dimension as well as total score (range 0 to 9400) will be measured.

    • Maximum change in mean arterial blood pressure from baseline during each test day (mmHg)

    • Maximum change from baseline during each test day (beats per minute)

    • Maximum change from baseline during each test day (SpO2)

    More Details

    NCT Number: NCT03341689
    Other IDs: 1607018057.A
    Study URL: https://clinicaltrials.gov/study/NCT03341689
    Last updated: Sep 29, 2023