Psilocybin: Motivation and Neurocognition in Individuals with Opioid Use Disorder (NIDA PSI)

This study is testing a substance called psilocybin to see how it affects the brain and thinking in people who are recovering from opioid addiction. Psilocybin is the main ingredient in “magic mushrooms.” In the body, it turns into a chemical called psilocin, which affects the brain's serotonin system. This can lead to experiences like changes in mood, emotions, or even mild hallucinations.

How long does it last?
Each person’s participation lasts 2 to 3 weeks with safety calls every three months out to one year post dosing day.

What happens during the study?

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 predose baseline visit in which you will fill out questionnaires and complete neurocognitive tasks; You will also undergo an fMRI.
• 2 preparation sessions with your therapy team before your psilocybin dose
• 1 psilocybin dosing day Participants are randomly assigned to take either 25 mg of psilocybin or 1 mg of psilocybin (8 hours long)
• 2 integration sessions with your therapy team after the dose
• 1 postdose visit in which you will complete the same items you completed during the baseline visit, to assess any differences after having been dosed with either 1 or 25 mg of psilocybin.

3. Follow up calls

• You will be called and asked questions about drug use as well as physical and mental health once every three months out to one year post dosing day.

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.

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

• Conditions: Opioid Use Disorder, opioid use, substance use, addiction, opioid addiction
• Age: 18 years - 60 years
• Gender: All