Psilocybin for the Treatment of Cluster Headache

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders

Sponsors

Lead Sponsor: Yale University

Collaborator: Heffter Research Institute
Cluster Headache-Trigeminal Autonomic Cephalalgia (CH-TAC), LLC

Source Yale University
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.

Overall Status Active, not recruiting
Start Date 2016-11-01
Completion Date 2022-06-01
Primary Completion Date 2022-06-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to first attack after completion of pulse regimen Two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Time to last attack after completion of pulse regimen Six months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Change in frequency of attacks Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in intensity of attacks Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in duration of attacks Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in cluster period duration compared to typical cluster period (episodic subjects only) 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
Difference in the change in cluster attack frequency between 1st and 2nd round Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Difference in the change in cluster attack intensity between 1st and 2nd round Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Difference in the change in the duration of attacks between 1st and 2nd round Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Secondary Outcome
Measure Time Frame
Use of abortive/rescue medication Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Attack-free time Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Health-Related Quality of life Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Psychedelic effects Taken daily on each experimental day after the resolution of psychedelic effects, approximately 6 hours after drug administration
Change in blood pressure 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)
Change in heart rate 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)
Change in peripheral oxygenation 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)
Enrollment 24
Condition
Intervention

Intervention Type: Drug

Intervention Name: 0.143 mg/kg Psilocybin or 10 mg Psilocybin

Description: 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)

Arm Group Label: Psilocybin High Dose

Intervention Type: Drug

Intervention Name: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin

Description: 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)

Arm Group Label: Psilocybin Low Dose

Intervention Type: Drug

Intervention Name: Placebo

Description: Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)

Arm Group Label: Placebo

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

Gender:

All

Minimum Age:

21 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Emmanuelle Schindler, MD, PhD

Phone: 203-932-5711

Phone Ext.: 4335

Email: [email protected]

Location
Facility: VA Connecticut Healthcare System
Location Countries

United States

Verification Date

2021-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Yale University

Investigator Full Name: Deepak C. D'Souza

Investigator Title: Professor of Psychiatry

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Psilocybin High Dose

Type: Active Comparator

Label: Psilocybin Low Dose

Type: Active Comparator

Label: Placebo

Type: Placebo Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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