NCT06724289

Psilocybin for Prolonged Grief Disorder

Psilocybin-Assisted Therapy for Prolonged Grief

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).

Detailed description

The study aims to investigate whether a single dose of 25 mg psilocybin can reduce the symptoms of grief and trauma associated with Prolonged Grief Disorder (PGD). It is hypothesized that psilocybin will significantly reduce the symptoms of PGD, and that the treatment will facilitate subjective mystical, spiritual, or insightful experiences, which in turn may contribute to the alleviation of grief and trauma symptoms. Neuroimaging will be used to help researchers better understand the relationship between grief and brain functions, comparing pre- and post-dose scans. Participants will undergo two MRI (magnetic resonance imaging) where they are asked to look at images (this is called a functional MRI or fMRI).

Conditions

• Prolonged Grief Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin 25 mg	25 mg psilocybin administered to each participant in single arm, open-label trial
DIAGNOSTIC_TEST	Functional Magnetic Resonance Imaging (fMRI)	There are two "fMRIs" (functional magnetic resonance imaging) that take place 1-14 days before and 1-14 days after psilocybin administration.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2024-12-09
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study