Mechanistic Studies of Psilocybin in Headache Disorders
ConditionMigraine
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-70
SponsorYale University
About this trial
In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 21 to 70 (inclusive)
Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient
Unstable medical condition or serious nervous system pathology
Pregnant, breastfeeding, lack of adequate birth control
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin
Drugsynthetic psilocybin 10 mg (oral)
Placebo
Drugsynthetic THC 2.5 mg (oral)
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: Migraine psilocybinExperimental treatment 1 intervention
Group B: Migraine placeboPlacebo comparator 1 intervention
Group C: Healthy control psilocybinExperimental treatment 1 intervention
Group D: Healthy control placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Baseline SV2A PET
Comparing initial SV2A PET between migraine and HC
Time frame
from date of randomization until the date of first PET scan, assessed up to 6 months2
Baseline RSFC
Comparing initial RSFC between migraine and HC
Time frame
from date of randomization until the date of first MRI, assessed up to 6 months3
Change in SV2A PET after drug administration
Comparing change in SV2A PET after drug between psilocybin/THC and migraine/HC
Time frame
from date of first PET scan to the date of second PET scan, assessed up to 6 months4
Change in resting state functional connectivity (RSFC) after drug administration
Comparing change in RSFC after drug between psilocybin/THC and migraine/HC
Time frame
from date of first MRI to the date of second MRI, assessed up to 6 monthsSecondary outcomes
1
Change in TNF-alpha
Comparing change in TNF-alpha levels after drug between psilocybin/THC and migraine/HC
Time frame
from screening to 7 days after drug administration2
Change in IL-1beta
Comparing change in IL-1beta levels after drug between psilocybin/THC and migraine/HC
Time frame
from screening to 7 days after drug administration3
Change in IL-6
Comparing change in IL-6 levels after drug between psilocybin/THC and migraine/HC
Time frame
from screening to 7 days after drug administration4
Change in calcitonin gene-related peptide (CGRP)
Comparing change in CGRP levels after drug between psilocybin/THC and migraine/HC
Time frame
from screening to 7 days after drug administrationOther outcomes
1
Acute change in TNF-alpha during drug administration
Comparing change in TNF-alpha between psilocybin/THC and migraine/HC
Time frame
0, 120, and 240 minutes after drug administration2
Acute change in IL-1beta during drug administration
Comparing change in IL-1beta between psilocybin/THC and migraine/HC
Time frame
0, 120, and 240 minutes after drug administration3
Acute change in IL-6 during drug administration
Comparing change in IL-6 between psilocybin/THC and migraine/HC
Time frame
0, 120, and 240 minutes after drug administration4
Acute change in calcitonin gene related peptide (CGRP) during drug administration
Comparing change in CGRP between psilocybin/THC and migraine/HC
Time frame
0, 120, and 240 minutes after drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
The Wallace Foundation
Collaborator
Source ClinicalTrials.gov