About the study
This is a mechanism study, not a treatment trial. Animal work suggests psilocybin promotes the growth of synapses in the prefrontal cortex; this study asks whether that happens in people, and specifically in people with opioid use disorder.
Participants who have completed detoxification undergo a PET scan using the radiotracer [11C]-UCB-J, which binds a protein found at synapses and so provides a direct measure of synaptic density. They receive psilocybin, then repeat the scan one to two weeks later. MRI scans before and after measure changes in resting-state connectivity, and behavioral assessments run alongside. The study is conducted largely on an inpatient basis, with the option to complete the second PET scan as an outpatient with twice-weekly urine testing in the interval.
Because of the imaging component, participation is more involved than in most of our studies. The enrollment target is small by design.
Is this study a fit?
The study team makes the final decision after screening. Final eligibility is determined in clinical screening, never by this page.
Who may be eligible
- Adults 25 to 55
- BMI between 19 and 35
- Meets DSM-5 criteria for opioid use disorder, with documented opioid use on screening urine toxicology
- More than one week of verified abstinence from illicit opioids
- Physically healthy on medical history, exam, neurological exam, ECG, and labs
- Willing to use dual contraception and to abstain from sperm or egg donation for the required interval
What would rule someone out
- Another substance use disorder besides nicotine
- Primary diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
- First-degree family history of a psychotic disorder or bipolar I/II
- Any history of psychosis, or of hallucinogen use disorder or HPPD
- Uncontrolled hypertension, heart rate outside 60–100 bpm, cardiovascular disease, or qualifying ECG findings
- Current serotonergic medications, or other psychoactive prescriptions that would interfere with safety or interpretation
- Any contraindication to MRI, or to arterial line placement (recent blood donation, bleeding disorder, anticoagulants)
- Research radiation exposure within the past year that would exceed annual limits
Final eligibility is determined in clinical screening, never by this page.
Does this sound like you? The next step is a short, no-commitment inquiry.
Check if I'm a fitStudy team
Study facts
Phase 1 · Target enrollment 12 · Sponsor: Yale University, with NIDA and the Yale Biomedical Imaging Institute · Site: Yale University, New Haven · PI: Gustavo Angarita, M.D. · Co-I Jamila Hokanson, M.D.
Contact & location
Inquire about this study
Sending an inquiry does not put you in a study and does not commit you. Whether a study is a fit is decided later, in screening.
- 1Send an inquiry
- 2A team member contacts you to answer your questions and, if you'd like, do a short phone pre-screen
- 3Screening, if it looks like a fit
Clinicians: use Refer a Patient. Not sure what happens after you write? What to expect if you inquire.
Contact the study team
- Phone
- (203) 444-1795
- Location
- Enact Research Collaborative
40 Temple St., 4th Floor, Suite 4C
New Haven, CT 06510
Registry title: Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD). View NCT06160284 on ClinicalTrials.gov (opens in a new tab)