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Exploring Psilocybin for Opioid Use Disorder

This study is exploring how psilocybin might affect the brain in people with Opioid Use Disorder (OUD). Researchers want to see if a single dose of psilocybin (20 mg or 25 mg, depending on your weight) can change how brain cells connect, which is called "synaptic density." You could be eligible if you are 25-55 years old, physically healthy, and have OUD confirmed by a doctor and recent opioid use shown in a urine test. The study will look at changes in your brain connections and how long it takes for you to relapse over 12 weeks. The study plans to enroll 12 participants and its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is not specified if it's randomized or blinded.
What's involved
You will undergo screening, then be admitted as an inpatient for about 1-2 weeks for detoxification, a baseline brain scan, psilocybin administration, and overnight observation. You may then be discharged and return twice weekly for urine tests before a second brain scan.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 weeks to measure time to relapse and brain changes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06160284

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

Recruiting
PHASE1Ages 25–55InterventionalBasic science
Yale University
~12 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Psilocybin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Synaptic Density
Measured over baseline and 1-2 weeks post treatment
+3 more outcomes measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Gustavo Angarita, MD, MHS · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Gustavo Angarita, MD, MHS
[email protected]
(203) 974-7536
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age between 25 and 55 years
BMI between 19 and 35 kg/m2
Voluntary, written, informed consent
Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
DSM-5 criteria for Opioid Use Disorder
Documented evidence (by urine toxicology) of opioid use (upon screening)
Inpatient verified \> 1 week of abstinence from illicit opioids
For females, a negative serum pregnancy (beta-HCG) test
Participants are required to commit to employing dual contraceptive methods throughout the study and to abstain from sperm or egg donation during the study period and for 28 days following the final drug dose for ova, and for 90 days following the final drug dose for sperm. Dual contraceptive methods encompass the use of a barrier contraceptive, such as condoms, coupled with another effective method capable of preventing pregnancy, such as oral or parenteral contraceptives, intrauterine devices, spermicide, and the like.

Exclusion

DSM-5 criteria for other substance use disorders (e.g., alcohol, cocaine, sedative hypnotics), except for nicotine (concurrent alcohol or drug use is allowed if it does not meet criteria for a substance use disorder and does not take place during inpatient stay)
A primary DSM-5 Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression, as determined by psychiatric history (Mini International Neuropsychiatric Interview, MINI) (Sheehan et al., 1998), or another disorder that may interfere with the study's primary outcomes in the view of PI
Immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders (e.g., delusional disorder, schizoaffective disorder), or bipolar I/II disorder
Individuals with a history or evidence of psychosis, including substance and nonsubstance related, as evaluated in assessments (MINI and Brief Psychiatric Rating Scale \[BPRS\]) before psilocybin administration
History of Hallucinogen Use Disorder or Hallucinogen Persisting Perceptive Disorder
A history of significant and/or uncontrolled medical or neurological illness
Hypertension at screening defined as: systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg
Heart rate outside the range of 60 to 100 beats per minute
History of cardiovascular disease, including but not limited to clinically significant coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, angina pectoris, coronary artery bypass graft or artificial heart valve, stroke, transient ischemic attack, or any clinically significant arrhythmia
Any clinically significant abnormal electrocardiogram (ECG) finding, such as findings suggestive of ischemia or infarct, complete bundle branch block, atrial fibrillation or other symptomatic arrhythmia, or predominantly non-sinus rhythm, at screening
Resting QT interval with Fridericia's correction (QTcF) ≥ 450 msec at Screening, or inability to determine QTcF interval
Presence of risk factors for torsades de pointes, including: long QT syndrome, uncontrolled hypokalemia or hypomagnesemia, history of cardiac failure, history of clinically significant/symptomatic bradycardia, family history of idiopathic sudden death or congenital long QT syndrome, or concomitant use of a torsadogenic medication
Current use of psychotropic and/or potentially psychoactive prescription medications considered to the investigators are likely to interfere clinically with human subject's safety (i.e., contraindicated drug-drug interactions with psilocybin) or scientifically (i.e., likely to influence or alter outcomes of the study)
Current use of medications with serotonergic activity, as participants on these medications are at risk of serotonin syndrome or drug-drug interactions
Medical contraindications to MRI procedures (e.g., ferromagnetic implants/foreign bodies, claustrophobia, etc.)
Arterial Line Exclusion: Blood donation within eight weeks of the start of the study
Arterial Line Exclusion: History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits followed by the Yale PET Center (21CFR361.1)
Moderate to severe hepatic impairment (Child-Pugh B and C class)
Use of enzyme inhibitors (UGT1A9, UGT1A10, MAO, and aldehyde or alcohol dehydrogenase).

What this trial measures

  • Change in Synaptic Densitybaseline and 1-2 weeks post treatment

    Change in synaptic density pre- and post- psilocybin administration will be measured using \[11C\]-UCB-J PET (volume of distribution \[VT\] and binding potential \[BPND\]) among OUD. The regions of interest (ROI) will be subregions of the prefrontal cortex identified by preclinical and preliminary clinical studies.

  • Association between VT and BPNDup to 12 weeks

    Association between VT and BPND assessed to determine whether changes in VT are associated with changes in BPND.

  • Time to relapseup to 12 weeks

    Mean number of days to relapse assessed by self- report

  • Urine toxicology post treatmentup to 12 weeks

    The mean number of positive urine tests post treatment will be assessed. Urine samples will be tested for the presence of opioids. A positive test indicates opioid usage in the last 2 weeks.