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Trial record 5 of 14 for:    psilocybin | Psilocybin | First posted from 07/30/2018 to 03/21/2020

Repeat Dosing of Psilocybin in Migraine Headache

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.
 
ClinicalTrials.gov Identifier: NCT04218539
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
Wallace Research Foundation
Information provided by (Responsible Party):
Yale University

Brief Summary:
In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: Psilocybin Drug: Placebo Phase 1

Detailed Description:
Migraine headache is a common medical condition and a top cause of disability worldwide. Treatment options for migraine headache are many and varied, though an approximated 10% of migraineurs is refractory to medication and thus, there is a need to develop alternative treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited dosing of psilocybin and related compounds in headache disorders. The cause of this unique effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a biological process relevant to migraine and other headache disorders. In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. The results from this study will serve in the development of larger investigations seeking to understand the effects of psilocybin and related compounds in headache disorders.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repeat Dosing of Psilocybin in Headache Disorders
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Placebo/Placebo
Subjects will receive a dose of placebo, followed by a dose of placebo approximately 7 days later.
Drug: Placebo
25mg Diphenhydramine

Experimental: Placebo/Psilocybin
Subjects will receive a dose of placebo, followed by a dose of psilocybin approximately 7 days later.
Drug: Psilocybin
10mg Psilocybin

Drug: Placebo
25mg Diphenhydramine

Experimental: Psilocybin/Placebo
Subjects will receive a dose of psilocybin, followed by a dose of placebo approximately 7 days later.
Drug: Psilocybin
10mg Psilocybin

Drug: Placebo
25mg Diphenhydramine

Experimental: Psilocybin/Psilocybin
Subjects will receive a dose of psilocybin, followed by a dose of psilocybin approximately 7 days later.
Drug: Psilocybin
10mg Psilocybin




Primary Outcome Measures :
  1. Change in migraine attack frequency [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    Average number (number per week)

  2. Change in pain intensity of migraine attacks [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

  3. Change in duration of migraine attacks [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    Average duration (measured in hours)

  4. Change in intensity of photophobia (light sensitivity) [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

  5. Change in intensity of phonophobia (noise sensitivity) [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

  6. Average intensity of nausea/vomiting [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

  7. Change in functional disability [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)


Secondary Outcome Measures :
  1. Use of abortive/rescue medication [ Time Frame: From two weeks before the first session to two months after second session using a headache diary ]
    number of times per week

  2. Time to first migraine attack [ Time Frame: From the second session until two months after second session using a headache diary ]
    Measured in days

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

  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 the first session to two 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, (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: Starting on the first test day until the second test day approximately one week later; taken both test days 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: Starting on the first test day until the second test day approximately one week later; measured both test sessions before drug administration, every 30 min in the first hour, then hourly for 4 hours or until resolution of drug effects (~6hrs after drug) ]
    Maximum change from baseline during each test day (mm Hg)

  7. Change in heart rate [ Time Frame: Starting on the first test day until the second test day approximately one week later; measured both test sessions before drug administration, every 30 min in the first hour, then hourly for 4 hours or until resolution of drug effects (~6hrs after drug) ]
    Maximum change from baseline during each test day (beats per minute)

  8. Change in peripheral oxygenation [ Time Frame: Starting on the first test day until the second test day approximately one week later; measured both test sessions before drug administration, every 30 min in the first hour, then hourly for 4 hours or until resolution of drug effects (~6hrs after drug) ]
    Maximum change from baseline during each test day (SpO2)

  9. Change in peripheral calcitonin gene-related peptide (CGRP) levels [ Time Frame: Approximately 3 months; measured at screening, on both test days (0, 2, and 4 hours after drug administration), and follow-up (~2 months after second test day) ]
    Change in peripheral neuropeptide levels

  10. Change in pituitary adenylate cyclase-activating peptide (PACAP) levels [ Time Frame: Approximately 3 months; measured at screening, on both test days (0, 2, and 4 hours after drug administration), and follow-up (~2 months after second test day) ]
    Change in peripheral neuropeptide levels



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.


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

Inclusion Criteria:

  • Diagnosis of migraine headache per ICHD-3 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

Exclusion Criteria:

  • Axis I psychotic or manic disorder (e.g., schizophrenia, bipolar I, depression with psychosis)
  • Axis I psychotic or manic 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, lysergic acid diethylamide (LSD), or related compounds
  • Drug abuse within the past 3 months (excluding tobacco)
  • Urine toxicology positive to drugs of abuse
  • Alcohol use of >21 drinks per week (males); >14 drinks per week (females; NIAAA guidelines)
  • Use of alcohol in the week prior to the first test day
  • 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
  • Use of migraine onabotulinum toxin (i.e., Botox) or monoclonal antibodies against CGRP or its receptor (i.e., erenumab) in the past month or while therapeutic effects are still present

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): NCT04218539


Contacts
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Contact: Kasey McKenna, BA 203-932-5711 ext 2526 kasey.mckenna@yale.edu
Contact: Emmanuelle Schindler, MD PhD 203-932-5711 ext 4335 emmanuelle.schindler@yale.edu

Sponsors and Collaborators
Yale University
Wallace Research Foundation

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04218539    
Other Study ID Numbers: 2000026974
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
psilocybin
inflammation
calcitonin gene-related peptide (CGRP)
pituitary adenylate cyclase-activating peptide (PACAP)
Additional relevant MeSH terms:
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Psilocybin
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs