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Completed

NCT Number: NCT03341689

Psilocybin for the Treatment of Migraine Headache

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.

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Key information

Conditions

Migraine Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Connecticut Healthcare System, West Haven Campus

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in migraine headache days

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

    Average days (number of days per week)

  2. Change in migraine attack frequency

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

    Average number (number per week)

  3. Change in migraine attack duration

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

    Average duration (measured in hours)

  4. Change in pain intensity of migraine attacks

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

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

  5. Change in intensity of nausea/vomiting during migraine attacks

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

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

  6. Change in intensity of photophobia

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

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

  7. Change in intensity of phonophobia

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

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

  8. Change in migraine attack-related functional disability

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

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

Secondary outcomes

  1. Change in the use of abortive/rescue medication

    Time frame: From two weeks before first session to two weeks after second session using a headache diary

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

  2. Time to first migraine attack

    Time frame: From the day of each session until two weeks after each test session

    Measured in days

  3. Time to second migraine attack

    Time frame: From the day of each session until two weeks after each test session

    Measured in days

  4. Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module

    Time frame: From two weeks before first session to three months after second session using a headache diary

    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.

  5. Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale

    Time frame: Taken on each test day approximately 6 hours after drug administration

    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.

  6. Change in blood pressure

    Time frame: Measured during each test session prior to drug administration, every 15 minutes in the first hour, every 30 minutes in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)

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

  7. Change in heart rate

    Time frame: Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)

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

  8. Change in peripheral oxygenation

    Time frame: Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)

    Maximum change from baseline during each test day (SpO2)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Ceruvia Lifesciences

Registry information

Official study title

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2017
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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