Mechanistic Studies of Psilocybin in Headache Disorders
- Registration Number
- NCT06464367
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Migraine psilocybin Psilocybin Migraine participants randomized to receive 10 mg psilocybin (oral) Migraine placebo Placebo Migraine participants randomized to receive 2.5 mg THC (oral) Healthy control psilocybin Psilocybin Healthy control participants randomized to receive 10 mg psilocybin (oral) Healthy control placebo Placebo Healthy control participants randomized to receive 2.5 mg THC
- Primary Outcome Measures
Name Time Method Change in SV2A PET after drug administration from date of first PET scan to the date of second PET scan, assessed up to 6 months Comparing change in SV2A PET after drug between psilocybin/THC and migraine/HC
Change in resting state functional connectivity (RSFC) after drug administration from date of first MRI to the date of second MRI, assessed up to 6 months Comparing change in RSFC after drug between psilocybin/THC and migraine/HC
Baseline SV2A PET from date of randomization until the date of first PET scan, assessed up to 6 months Comparing initial SV2A PET between migraine and HC
Baseline RSFC from date of randomization until the date of first MRI, assessed up to 6 months Comparing initial RSFC between migraine and HC
- Secondary Outcome Measures
Name Time Method Change in TNF-alpha from screening to 7 days after drug administration Comparing change in TNF-alpha levels after drug between psilocybin/THC and migraine/HC
Change in IL-1beta from screening to 7 days after drug administration Comparing change in IL-1beta levels after drug between psilocybin/THC and migraine/HC
Change in bedtime (via actigraphy) from screening through 14 days after drug administration Comparing change in bedtime (time) after drug between psilocybin/THC and migraine/HC
Change in get-up time (via actigraphy) from screening through 14 days after drug administration Comparing change in get-up time (time) after drug between psilocybin/THC and migraine/HC
Change in daily active period (via actigraphy) from screening through 14 days after drug administration Comparing change in daily active period (hours) after drug between psilocybin/THC and migraine/HC
Change in daily rest period (via actigraphy) from screening through 14 days after drug administration Comparing change in daily rest period (hours) after drug between psilocybin/THC and migraine/HC
Change in REM latency (via sleep electroencephalography) from screening to 7 days after drug administration Comparing change in REM latency (minutes) after drug between psilocybin/THC and migraine/HC
Change in percent REM (via sleep electroencephalography) from screening to 7 days after drug administration Comparing change in percent REM (%) after drug between psilocybin/THC and migraine/HC
Change in IL-6 from screening to 7 days after drug administration Comparing change in IL-6 levels after drug between psilocybin/THC and migraine/HC
Change in calcitonin gene-related peptide (CGRP) from screening to 7 days after drug administration Comparing change in CGRP levels after drug between psilocybin/THC and migraine/HC
Change in pituitary adenylate cyclase activating polypeptide (PACAP) from screening to 7 days after drug administration Comparing change in PACAP levels after drug between psilocybin/THC and migraine/HC
Adverse events from screening through 3 months after drug administration Adverse events from any procedure or drug administration
Change in sleep efficiency (via sleep electroencephalography) from screening to 7 days after drug administration Comparing change in sleep efficiency (%) after drug between psilocybin/THC and migraine/HC
Trial Locations
- Locations (1)
VA Connecticut Healthcare System
🇺🇸West Haven, Connecticut, United States