Psilocybin for the Treatment of Cluster Headache

Psilocybin

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.

Intervention / Treatment

  • 0.143 mg/kg Psilocybin or 10 mg Psilocybin (DRUG)
    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)
  • 0.0143 mg/kg Psilocybin or 1 mg Psilocybin (DRUG)
    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)
  • Placebo (DRUG)
    Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)

Condition or Disease

  • Cluster Headache

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Active, not recruiting
    Study results: No Results Available
    Age: 21 Years to 65 Years
    Enrollment: 24 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Nov 01, 2016
    Primary Completion: Jun 30, 2022 ACTUAL
    Completion Date: Sep 30, 2023 ESTIMATED
    Study First Posted: Dec 05, 2016 ESTIMATED
    Results First Posted: Aug 30, 2020
    Last Updated: Jun 13, 2023

    Sponsors / Collaborators

    Lead Sponsor: Yale University
    Responsible Party: N/A

    Location

    West Haven, Connecticut, USA

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 21
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Measured in days

    • Measured in days

    • Average number of attacks (number per week)

    • Average intensity of attacks (1-10 on visual analog scale)

    • Average duration of attacks (minutes)

    • Duration of cluster period after intervention (days)

    • Average number of attacks (number per week); only in those subjects who return for 2nd round

    • Average intensity of attacks (1-10 on visual analog scale); only in those subjects who return for 2nd round

    • Average duration of attacks (minutes); only in those subjects who return for 2nd round

    Secondary Outcomes

    • Number of times per week

    • Number of 24 hour days (may be nonconsecutive)

    • Using the CDC's Health-Related Quality of Life (HRQOL) scale

    • Using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale

    • Maximum change from baseline during each experimental session (mmHg)

    • Maximum change from baseline during each experimental session (beats per minute)

    • Maximum change from baseline during each experimental session (SpO2)

    More Details

    NCT Number: NCT02981173
    Other IDs: 1607018057
    Study URL: https://clinicaltrials.gov/study/NCT02981173
    Last updated: Sep 29, 2023