NCT06810310

Psilocybin on Brain Mechanisms of Motivation in OUD

Psilocybin: Capturing Brain Mechanisms of Motivation and Neurocognition in Individuals With Opioid Use Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Anna Rose Childress, Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to test addiction-related brain circuitry (motivation/reward and inhibition) as well as neurocognitive circuitry prior to and following low or high dose psilocybin (PEX010 from Filament). Using fMRI, we will examine brain circuits relevant to drug relapse as well as neurocognitive flexibility circuits in individuals with opioid use disorder. We will randomize 24 males and females, aged 18 - 60, in the greater Philadelphia area, to either 1mg or 25 mg of psilocybin. Participants will 1. come to our offices for screening visits - these are assessments, interviews, and some medical tests (such as a history and physical, as well as a fasting blood draw) to help us determine eligibility for our study. 2. If not already in an inpatient setting, participants be admitted to an inpatient program for the duration of the psilocybin phases - about two weeks. During this time, they will be brought to our offices at 3535 Market Street in Philadelphia for about 7 visits. These visits include pre-dose psilocybin preparation therapy, baseline assessments and neuropsychological testing, psilocybin dosing, post dose therapy visits, and post dose assessments.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin (high dose)	PEX010 is the psilocybin produced by Filament
DRUG	psilocybin (low dose)	1mg psilocybin, produced by Filament

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-02-05
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study