Actively Recruiting

Phase 1
Age: 21Years - 55Years
All Genders
NCT06160284

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

Led by Yale University · Updated on 2025-05-29

12

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary, written, informed consent
  • Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
  • Meet DSM-5 criteria for Opioid Use Disorder
  • Documented opioid use by urine toxicology at screening
  • Verified abstinence from opioids for more than 1 week as an inpatient
  • For females, negative serum pregnancy (beta-HCG) test
Not Eligible

You will not qualify if you...

  • DSM-5 criteria for other substance use disorders except nicotine, unless concurrent use does not meet disorder criteria and does not occur during inpatient stay
  • Primary diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, major depression, or other interfering psychiatric disorders
  • Immediate family history of schizophrenia, psychotic disorders, or bipolar I/II disorder
  • Significant or uncontrolled medical or neurological illness
  • Hypertension with systolic >140 mmHg or diastolic >90 mmHg at screening
  • History of cardiovascular disease including coronary artery disease, heart failure, stroke, arrhythmias
  • Abnormal ECG findings such as ischemia, infarct, bundle branch block, atrial fibrillation, or non-sinus rhythm
  • Resting QT interval ≥450 msec (male) or ≥470 msec (female) or inability to determine QTcF
  • Risk factors for torsades de pointes such as long QT syndrome, electrolyte imbalances, cardiac failure history, symptomatic bradycardia, family history of sudden death, or use of torsadogenic medications
  • Use of psychotropic or psychoactive medications interfering with safety or study outcomes
  • Contraindications to MRI (e.g., ferromagnetic implants, claustrophobia)
  • Blood donation within 8 weeks before study start
  • History of bleeding disorders or current use of anticoagulants
  • Participation in other radiation-involving research within one year that exceeds dose limits at Yale PET Center

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

G

Gustavo Angarita, MD, MHS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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