Psilocybin: Capturing Brain Mechanisms of Motivation and Neurocognition in Individuals With Opioid Use Disorder
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, brain circuits will be examined that are relevant to drug relapse as well as neurocognitive flexibility circuits in individuals with opioid use disorder. Investigators will randomize 24 males and females, aged 18 - 60, in the greater Philadelphia area, to either 1mg or 25 mg of psilocybin. Participants will 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 determine eligibility for our study. If eligible, participants will be brought to research 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.
- Status
- recruiting
- Phase
- Phase 2
- Institution
- University of Pennsylvania
- Start date
- 2025-12-22
- End date
- 2027-05-01
- Registry ID
- NCT06810310
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.