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

This open-label trial (n=12) will explore the synaptotrophic effects of psilocybin (25mg) in individuals with opioid use disorder (OUD).

Conducted by Yale University, participants will undergo pre- and post-psilocybin administration PET scans with the [11C]-UCB-J radiotracer while inpatient. The study involves screening of OUD subjects as outpatients at the Clinical Neuroscience Research Unit (CNRU), followed by inpatient admission.

Subjects will receive a single dose of psilocybin, administered intravenously based on weight. PET scans will be conducted at the Yale PET Center before and after psilocybin administration.

The primary outcome measure is the change in synaptic density measured using [11C]-UCB-J PET, with secondary measures including time to relapse and changes in vital signs, mood states, and withdrawal symptoms.

Recruitment for this phase I trial began in January 2024, with an estimated enrolment of 12 participants.

Topic Opioid Use Disorder Addiction
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 January 2024
End date 31 January 2027
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 12
Sex All
Age 21- 55
Therapy No

Trial Details

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.

NCT Number NCT06160284

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

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