Psilocybin on Brain Mechanisms of Motivation in OUD

This randomised, quadruple-masked (participant, care provider, investigator, outcomes assessor), interventional Phase II trial (n=24) will study the effects of psilocybin (1mg or 25mg; PEX010) on brain mechanisms related to motivation, reward, and cognitive flexibility in individuals with opioid use disorder (OUD). Participants will receive either a low dose (1mg) or a high dose (25mg) of psilocybin (PEX010, produced by Filament) in a single session.

The study, led by Dr. Anna Rose Childress at the University of Pennsylvania, aims to examine how psilocybin affects brain circuits involved in drug relapse and self-control using functional MRI (fMRI).

Participants, aged 18-60, will be in an inpatient addiction treatment facility during the psilocybin phase, which lasts approximately two weeks. They will undergo preparatory therapy, baseline assessments, neuropsychological testing, psilocybin administration, and post-dose therapy sessions. The primary outcome measures include brain responses to drug-related cues and cognitive tasks before and after psilocybin administration. The study is expected to run from March 2025 to May 2026.

Trial Details

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.

Trial Number NCT06810310

Data attribution

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