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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

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ClinicalTrials.gov Identifier: NCT04218539
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Wallace Research Foundation
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE December 20, 2019
First Posted Date  ICMJE January 6, 2020
Last Update Posted Date May 27, 2020
Estimated Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date July 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 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
  • Time to first migraine attack [ Time Frame: From the second session until two months after second session using a headache diary ]
    Measured in days
  • 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)
  • 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
  • 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.
  • Change in blood pressure- Systolic [ 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)
  • Change in blood pressure- Diastolic [ 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)
  • 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)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
  • 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
  • Time to first migraine attack [ Time Frame: From the second session until two months after second session using a headache diary ]
    Measured in days
  • 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)
  • 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
  • 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.
  • 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)
  • 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)
  • 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)
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeat Dosing of Psilocybin in Migraine Headache
Official Title  ICMJE Repeat Dosing of Psilocybin in Headache Disorders
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Drug: Psilocybin
    10mg Psilocybin
  • Drug: Placebo
    25mg Diphenhydramine
Study Arms  ICMJE
  • Experimental: Placebo/Placebo
    Subjects will receive a dose of placebo, followed by a dose of placebo approximately 7 days later.
    Intervention: Drug: Placebo
  • Experimental: Placebo/Psilocybin
    Subjects will receive a dose of placebo, followed by a dose of psilocybin approximately 7 days later.
    Interventions:
    • Drug: Psilocybin
    • Drug: Placebo
  • Experimental: Psilocybin/Placebo
    Subjects will receive a dose of psilocybin, followed by a dose of placebo approximately 7 days later.
    Interventions:
    • Drug: Psilocybin
    • Drug: Placebo
  • Experimental: Psilocybin/Psilocybin
    Subjects will receive a dose of psilocybin, followed by a dose of psilocybin approximately 7 days later.
    Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2023
Estimated Primary Completion Date July 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04218539
Other Study ID Numbers  ICMJE 2000026974
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Wallace Research Foundation
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP