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Psilocybin for the Treatment of Migraine Headache

This study is currently recruiting participants.
Verified November 2017 by Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03341689
First Posted: November 14, 2017
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  Purpose
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, in both the short and long-term.

Condition Intervention Phase
Migraine Headache Drug: High Dose Psilocybin Drug: Low Dose Psilocybin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Acute change in pain intensity [ Time Frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration ]
    4-tiered pain score (1=none, 2=mild, 3=moderate, 4=severe)

  • Acute change in nausea/vomiting [ Time Frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration ]
    4-tiered pain score (1=none, 2=mild, 3=moderate, 4=severe)

  • Acute change in photophobia [ Time Frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration ]
    4-tiered pain score (1=none, 2=mild, 3=moderate, 4=severe)

  • Acute change in phonophobia [ Time Frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration ]
    4-tiered pain score (1=none, 2=mild, 3=moderate, 4=severe)

  • Acute change in functional disability [ Time Frame: Measured at 0, 1, 2, 4, and 24 hours after drug administration ]
    4-tiered pain score (1=none, 2=mild, 3=moderate, 4=severe)

  • Time to first migraine attack [ Time Frame: Two weeks following each test session ]
    Measured in days

  • Time to last migraine attack [ Time Frame: Two weeks following each test session ]
    Measured in days

  • 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)

  • 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)

  • 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; 1=none, 2=mild, 3=moderate, 4=severe)

  • 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; 1=none, 2=mild, 3=moderate, 4=severe)

  • 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; 1=none, 2=mild, 3=moderate, 4=severe)

  • 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; 1=none, 2=mild, 3=moderate, 4=severe)

  • Change in 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; 1=none, 2=mild, 3=moderate, 4=severe)


Secondary Outcome Measures:
  • 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 times per week

  • Migraine attack-free time [ Time Frame: From two weeks before first session to two weeks after second session using a headache diary ]
    Number of 24 hour days (may be non-consecutive)

  • Quality of life [ Time Frame: From two weeks before first session to three months after second session using a headache diary ]
    Using the CDC's Health-Related Quality of Life Scale

  • Psychedelic effects [ Time Frame: Taken on each test day approximately 6 hours after drug administration ]
    Using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale

  • Change in blood pressure [ 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 (mmHg)

  • 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)

  • 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)


Estimated Enrollment: 24
Actual Study Start Date: November 1, 2017
Estimated Study Completion Date: March 1, 2020
Estimated Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Drug: Low Dose Psilocybin
0.0143 mg/kg psilocybin capsule
Drug: Placebo
microcrystalline cellulose capsule
Experimental: Placebo/High Dose Psilocybin
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
Drug: High Dose Psilocybin
0.143 mg/kg psilocybin capsule
Drug: Placebo
microcrystalline cellulose capsule
Experimental: Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Drug: Low Dose Psilocybin
0.0143 mg/kg psilocybin capsule
Drug: Placebo
microcrystalline cellulose capsule
Experimental: High Dose Psilocybin/Placebo
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
Drug: High Dose Psilocybin
0.143 mg/kg psilocybin capsule
Drug: Placebo
microcrystalline cellulose capsule

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of migraine headache per ICHD-3beta criteria
  • Typical pattern of migraine attacks with approximately two migraines or more weekly
  • 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) in the past 2 weeks
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341689


Contacts
Contact: Emmanuelle Schindler, MD, PhD 203-932-5711 ext 4335 emmanuelle.schindler@va.gov
Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System, West Haven Campus Recruiting
West Haven, Connecticut, United States, 06516
Contact: Emmanuelle Schindler, MD, PhD    203-932-5711 ext 4335    emmanuelle.schindler@va.gov   
Contact: Christina Luddy, BS    203-932-5711 ext 4549    christina.luddy@yale.edu   
Principal Investigator: Deepak C D'Souza, M.D.         
Sponsors and Collaborators
Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03341689     History of Changes
Other Study ID Numbers: 1607018057.A
First Submitted: November 9, 2017
First Posted: November 14, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Psilocybin

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs