Mechanistic Studies of Psilocybin in Headache Disorders

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06464367
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin — DRUG
    synthetic psilocybin 10 mg (oral)
  • Placebo — DRUG
    synthetic THC 2.5 mg (oral)

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Migraine psilocybin
    Migraine participants randomized to receive 10 mg psilocybin (oral)
  • Placebo Comparator: Migraine placebo
    Migraine participants randomized to receive 2.5 mg THC (oral)
  • Experimental: Healthy control psilocybin
    Healthy control participants randomized to receive 10 mg psilocybin (oral)
  • Placebo Comparator: Healthy control placebo
    Healthy control participants randomized to receive 2.5 mg THC

Primary Outcome Measure

Baseline SV2A PET [ Time Frame: from date of randomization until the date of first PET scan, assessed up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516
Sarah Anthony, MSc
[email protected]
203-932-5711
Emmanuelle Schindler, MD, PhD
[email protected]
203-932-5711

Find similar trials in West Haven, CT

By condition
Migraine
By specialty
Neurology
By research site
VA Connecticut Healthcare System· West Haven, CT

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