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Psilocybin for the Treatment of Cluster Headache

This study is currently recruiting participants.
Verified June 2017 by Deepak C. D'Souza, Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981173
First Posted: December 5, 2016
Last Update Posted: June 23, 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.
Collaborator:
Heffter Research Institute
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
  Purpose
The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen.

Condition Intervention Phase
Cluster Headache Drug: 0.143 mg/kg Psilocybin Drug: 0.0143 mg/kg Psilocybin Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Psilocybin for the Treatment of Cluster Headache

Resource links provided by NLM:


Further study details as provided by Deepak C. D'Souza, Yale University:

Primary Outcome Measures:
  • Time to first attack after completion of pulse regimen [ Time Frame: Two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3) ]
    Measured in days

  • Time to last attack after completion of pulse regimen [ Time Frame: Six months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3) ]
    Measured in days

  • Change in frequency of attacks [ Time Frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary ]
    Average number of attacks (number per week)

  • Change in intensity of attacks [ Time Frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary ]
    Average intensity of attacks (1-10 on visual analog scale)

  • Change in duration of attacks [ Time Frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary ]
    Average duration of attacks (minutes)

  • Change in cluster period duration compared to typical cluster period (episodic subjects only) [ Time Frame: Measured from 2 weeks before pulse regimen to 6 months following the completion of pulse regimen, then comparing to historical average duration of cluster periods ]
    Duration of cluster period after intervention (days)


Secondary Outcome Measures:
  • Use of abortive/rescue medication [ Time Frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary ]
    Number of times per week

  • Attack-free time [ Time Frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary ]
    Number of 24 hour days (may be nonconsecutive)

  • Quality of life [ Time Frame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary ]
    Using the CDC's Health-Related Quality of Life (HRQOL) scale

  • Psychedelic effects [ Time Frame: Taken daily on each experimental day after the resolution of psychedelic effects, 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 experimental session prior to drug administration, every 15 min in the first hour after drug administration, 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 experimental session (mmHg)

  • Change in heart rate [ Time Frame: Measured during each experimental session prior to drug administration, every 15 min in the first hour after drug administration, 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 experimental session (beats per minute)

  • Change in peripheral oxygenation [ Time Frame: Measured during each experimental session prior to drug administration, every 15 min in the first hour after drug administration, 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 experimental session (SpO2)


Estimated Enrollment: 24
Study Start Date: November 2016
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Psilocybin High Dose Drug: 0.143 mg/kg Psilocybin
0.143 mg/kg psilocybin capsule ingested on each of three test days (5 days apart +/- 1-2 days)
Active Comparator: Psilocybin Low Dose Drug: 0.0143 mg/kg Psilocybin
0.0143 mg/kg psilocybin capsule ingested on each of three test days (5 days apart +/- 1-2 days)
Placebo Comparator: Placebo Drug: Placebo
Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Chronic cluster headache with at least one attack daily
  • Episodic cluster headache with periods that are predictable and have a duration of approximately 2 months
  • Attacks respond to high-flow oxygen

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, lysergic acid diethylamide (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 two weeks
  • Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
  • Use of antidepressant medications (i.e. amitriptyline, isocarboxazid, fluoxetine, citalopram) 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): NCT02981173


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

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

Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02981173     History of Changes
Other Study ID Numbers: 1607018057
First Submitted: November 11, 2016
First Posted: December 5, 2016
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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