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Psilocybin for the Treatment of Cluster Headache

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ClinicalTrials.gov Identifier: NCT02981173
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : January 8, 2021
Sponsor:
Collaborators:
Heffter Research Institute
Cluster Headache-Trigeminal Autonomic Cephalalgia (CH-TAC), LLC
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Tracking Information
First Submitted Date  ICMJE November 11, 2016
First Posted Date  ICMJE December 5, 2016
Last Update Posted Date January 8, 2021
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • 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)
  • Difference in the change in cluster attack frequency between 1st and 2nd round [ Time Frame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary ]
    Average number of attacks (number per week); only in those subjects who return for 2nd round
  • Difference in the change in cluster attack intensity between 1st and 2nd round [ Time Frame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary ]
    Average intensity of attacks (1-10 on visual analog scale); only in those subjects who return for 2nd round
  • Difference in the change in the duration of attacks between 1st and 2nd round [ Time Frame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary ]
    Average duration of attacks (minutes); only in those subjects who return for 2nd round
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • 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
  • 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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • 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)
  • Health-Related 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin for the Treatment of Cluster Headache
Official Title  ICMJE Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders
Brief Summary 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. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cluster Headache
Intervention  ICMJE
  • Drug: 0.143 mg/kg Psilocybin or 10 mg Psilocybin
    0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
  • Drug: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin
    0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
  • Drug: Placebo
    Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)
Study Arms  ICMJE
  • Active Comparator: Psilocybin High Dose
    Intervention: Drug: 0.143 mg/kg Psilocybin or 10 mg Psilocybin
  • Active Comparator: Psilocybin Low Dose
    Intervention: Drug: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 are managed by means involving no more than twice weekly triptan use (e.g., high-flow oxygen, heat/cold pack)

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) within five half-lives of test days
  • 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
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: Emmanuelle Schindler, MD, PhD 203-932-5711 ext 4335 emmanuelle.schindler@yale.edu
Contact: Christina Forte, BA 203-932-5711 ext 2526 christina.forte@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02981173
Other Study ID Numbers  ICMJE 1607018057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deepak C. D'Souza, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • Heffter Research Institute
  • Cluster Headache-Trigeminal Autonomic Cephalalgia (CH-TAC), LLC
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date January 2021

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