Clinical trial NCT02981173: Psilocybin for the Treatment of Cluster Headache
Official title: Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cluster Headache
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Heffter Research Institute
name: Ceruvia Lifesciences
name: CH TAC LLC
First posted: 2016-12-05
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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 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:
measure: Time to first attack after completion of pulse regimen
timeFrame: Two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
measure: Time to last attack after completion of pulse regimen
timeFrame: Six months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
measure: Change in frequency of attacks
timeFrame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
measure: Change in intensity of attacks
timeFrame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
measure: Change in duration of attacks
timeFrame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
measure: Change in cluster period duration compared to typical cluster period (episodic subjects only)
timeFrame: 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
measure: Difference in the change in cluster attack frequency between 1st and 2nd round
timeFrame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
measure: Difference in the change in cluster attack intensity between 1st and 2nd round
timeFrame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
measure: Difference in the change in the duration of attacks between 1st and 2nd round
timeFrame: Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Secondary outcomes:
measure: Use of abortive/rescue medication
timeFrame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
measure: Attack-free time
timeFrame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
measure: Health-Related Quality of life
timeFrame: Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
measure: Psychedelic effects
timeFrame: Taken daily on each experimental day after the resolution of psychedelic effects, approximately 6 hours after drug administration
measure: Change in blood pressure
timeFrame: 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)
measure: Change in heart rate
timeFrame: 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)
measure: Change in peripheral oxygenation
timeFrame: 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)
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References: