Psilocybin for the Treatment of Migraine Headache

Migraine Headache Clinical Trial

Official title:

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341689
• Other study ID #: 1607018057.A
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2017
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.

Description:

The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of migraine headache per ICHD-3beta criteria

• Typical pattern of migraine attacks with approximately two migraines or more weekly

• Attacks are managed by means involving no more than twice weekly triptan use

• Age 21 to 65

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, 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 5 half-lives of test days

• Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks

• Use of antidepressant medication (i.e. TCA, MAOI, SSRI) in the past 6 weeks

• Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• High Dose Psilocybin
0.143 mg/kg psilocybin capsule
• Low Dose Psilocybin
0.0143 mg/kg psilocybin capsule
• Placebo
microcrystalline cellulose capsule

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System, West Haven Campus	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Ceruvia Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in migraine headache days	Average days (number of days per week)	From two weeks before first session to two weeks after second session using a headache diary
Primary	Change in migraine attack frequency	Average number (number per week)	From two weeks before first session to two weeks after second session using a headache diary
Primary	Change in migraine attack duration	Average duration (measured in hours)	From two weeks before first session to two weeks after second session using a headache diary
Primary	Change in pain intensity of migraine attacks	Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)	From two weeks before first session to two weeks after second session using a headache diary
Primary	Change in intensity of nausea/vomiting during migraine attacks	Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)	From two weeks before first session to two weeks after second session using a headache diary
Primary	Change in intensity of photophobia	Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)	From two weeks before first session to two weeks after second session using a headache diary
Primary	Change in intensity of phonophobia	Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)	From two weeks before first session to two weeks after second session using a headache diary
Primary	Change in migraine attack-related functional disability	Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)	From two weeks before first session to two weeks after second session using a headache diary
Secondary	Change in the use of abortive/rescue medication	number of days (number of days per week using a migraine abortive)	From two weeks before first session to two weeks after second session using a headache diary
Secondary	Time to first migraine attack	Measured in days	From the day of each session until two weeks after each test session
Secondary	Time to second migraine attack	Measured in days	From the day of each session until two weeks after each test session
Secondary	Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module	4 questions scored 0 to 30 each; higher numbers indicate worse quality of life.; (1) pain-related impairment, (2) mood symptoms, (3) anxiety symptoms, and (4) lack of sleep Percent change for each measure as well as total score (range 0 to 120) will be calculated.	From two weeks before first session to three months after second session using a headache diary
Secondary	Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale	94 questions scored 0 to 100 each; higher numbers indicate greater psychedelic effects Questions address 5 dimensions: (1) Oceanic boundlessness (score range 0-2700), (2) Dread of Ego Dissolution (score range 0-2100), (3) Visionary Restructuralization (score range 0-1800), (4) Auditory Alterations (score range 0-1600), and (5) Vigilance reduction (score range 0-1200) Score for each dimension as well as total score (range 0 to 9400) will be measured.	Taken on each test day approximately 6 hours after drug administration
Secondary	Change in blood pressure	Maximum change in mean arterial blood pressure from baseline during each test day (mmHg)	Measured during each test session prior to drug administration, every 15 minutes in the first hour, every 30 minutes in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)
Secondary	Change in heart rate	Maximum change from baseline during each test day (beats per minute)	Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)
Secondary	Change in peripheral oxygenation	Maximum change from baseline during each test day (SpO2)	Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)