NCT06160284

Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the synaptotrophic effects of psilocybin among medically healthy, detoxified OUD subjects. Eligible OUD participants will undergo pre- and post- psilocybin administration PET scans with the \[11C\]-UCB-J radiotracer while inpatient.

Detailed description

Participants will undergo screening as outpatients at the Clinical Neuroscience Research Unit (CNRU). Once deemed eligible, OUD subjects will be studied as inpatients. However, they will have the option of scheduling their second \[11C\]-UCB-J PET as an outpatient (pending these participants' agreement to undergo outpatient visits twice per week to provide urine toxicology to monitor abstinence before PET). The only portion of the study that will be available as outpatient for OUD subjects will be the 1-2 weeks before the second \[11C\]-UCB-J PET scan. The subject will still be admitted for 1-2 weeks, which will include: inpatient detoxification, baseline \[11C\]-UCB-J PET scan, psilocybin administration, and overnight observation after psilocybin administration. However, they may be discharged the day following psilocybin administration and return 2x weekly for urine toxicology testing between discharge and the second \[11C\]-UCB-J PET to confirm abstinence. Structural magnetic resonance imaging (MRI) scans will be obtained for anatomical registration/partial volume correction from all subjects. Functional MRI (fMRI) scans will be completed pre- and post-psilocybin administration to evaluate changes in resting state connectivity. All subjects will participate in a battery of behavioral assessments for exploratory correlations with \[11C\]-UCB-J. Inpatient subjects who smoke cigarettes will have the option of using nicotine gum and/or nicotine patch while on the unit in order to prevent or minimize nicotine withdrawal. The \[11C\]-UCB-J PET scans will be done at the Yale PET Center 1-2 weeks before (baseline) and after psilocybin administration. This is a single-center study at Yale, that will have study activities completed at the following areas: * Clinical Neuroscience Research Unit (CNRU) of the Connecticut Mental Health Center (CMHC) * Yale Positron Emission Tomography (PET) Imaging Center * Yale Magnetic Resonance Research Center (MRRC)

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin	Participants will receive a single dose of psilocybin administered in 20 mg or 25 mg doses depending on the participant's weight: 20 mg (among participants \< 70 kg) or 25 mg (among participants \>70 kg). Participants will be administered psilocybin at CNRU, within 1-2 weeks of the baseline \[11C\]-UCB-J PET.

Timeline

• Start date: 2025-05-28
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-12-07
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study