Can Psilocybin Improve Brain, Behavioral, and Clinical Outcomes in Opioid Use Disorder (OUD)? (Wellcome Leap)

Study Overview

We are looking for 36 people who are currently on medication-assisted treatment (MAT) for opioid use disorder (OUD) to take part in a research study. The goal is to see if a study medication called PEX010 (25 mg/day) has any effects on brain function, thinking skills, and health outcomes.

Participants will be randomly placed into one of two groups:

• PEX010-25 group – receives a 25 mg dose
• PEX010-1 group – receives a 1 mg dose

Study Timeline

Your participation will last about 11 weeks (around 3 months) with follow ups afterwards every three months out to a year.. Here's what the study includes:

1. Screening visit (1 day)

We’ll check to make sure you qualify for the study and that it’s safe for you to join.

2. Dosing phase (2 weeks)

During this time, you’ll go through the following steps:

• 1 baseline assessment in which you fill out questionnaires and complete neurocognitive testing as well as complete some tasks while wearing an fNIRS headband
• 2 preparation sessions with your therapy team before your psilocybin dose
• 1 psilocybin dosing day (8 hours long)
• 2 integration sessions with your therapy team after the dose
• 1 post dose assessment day in which you complete the same items as in baseline

3. Outcomes Visits (8 weeks)

• You’ll visit the study site twice a week for 8 weeks.

4. Follow-up

• After dosing, you’ll return for research visits every 3 months for one year.

What Else to Know

• You must be able to attend all visits to participate.
• You’ll receive payment for your time and travel after each visit.

We’ll check your drug use, mental health, and physical health throughout the study. Some visits will include computer-based tasks and you might wear a light-sensitive headband that tracks brain activity (called fNIRS).

You may also be invited to take part in a special brain scan called fMRI (functional magnetic resonance imaging).

You may be eligible for this study if you meet the following criteria:

• Conditions: Opioid Use Disorder, OUD, Opioid Use
• Age: 18 years - 65 years
• Gender: All