Psilocybin for Opioid Use Disorder
This study is looking at how psilocybin (PEX010 from Filament) affects the brain in people with opioid use disorder. Researchers want to understand how different doses of psilocybin (1mg or 25mg) impact brain circuits related to motivation, reward, and the ability to stop drug-seeking behaviors. They will use fMRI (functional magnetic resonance imaging) scans to measure these brain changes before and after psilocybin is given. The study aims to enroll 24 adults, aged 18 to 60, in the Philadelphia area. To be eligible, you must have a confirmed prescription for BUP-NX, or have recently received Sublocade, or be currently on another specific medication. The study is currently unclear on its recruitment status.
- Study design
- This interventional study plans to enroll 24 participants, who will be randomly assigned to receive either a low (1mg) or high (25mg) dose of psilocybin.
- What's involved
- You will have screening visits that include assessments, interviews, a physical exam, and a fasting blood draw to check if you can join the study. Brain and behavioral measurements will be taken one week before and one week after receiving the psilocybin dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Brain and behavioral measures will be taken one week after the psilocybin dose.
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NCT06810310
Psilocybin on Brain Mechanisms of Motivation in OUD
Recruiting
PHASE2Ages 18–60InterventionalBasic scienceUniversity of PennsylvaniaInvestigator-initiated
~24 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Psilocybin (high dose)psilocybin (low dose)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brain measure of GO domain
Measured over One week pre dose and one week post dose
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
An informed consent document voluntarily signed and dated by the subject.
Either 1) have a confirmed prescription for BUP-NX in a drug monitoring program database, have been on a stable dose of BUP-NX for at least one week, and plan to continue taking BUP-NX for at least 12 weeks or 2) have received an injection of Sublocade® within the past month, or 3) are currently on methadone maintenance therapy and on a consistent dose for at least a week. Subject must provide a urine that is buprenorphine-positive (for subjects taking buprenorphine) or methadone-positive (for subjects taking methadone), during screening.
Physically healthy males and females, aged 18-60 years old, who meet criteria for opioid use disorder (based on DSM-5 criteria) as their primary diagnosis and are voluntarily seeking treatment.
Females must be non-pregnant and non-lactating. Additionally, for females with childbearing potential (i.e., have not undergone sterilization via hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or at least 1 year post-menopausal) participants must agree to use an acceptable form of contraception (e.g. abstinence, intrauterine device, hormonal injection, hormonal implant, hormonal patch/ring/pill, condoms (male or female), etc.) during study participation and to continue its use for the duration of the study
Subject must read at or above eighth grade level and speak, understand, and write in English.
IQ score of greater than or equal to 80.
Exclusion
Participation in clinical trial and receipt of investigational drug(s) during 30 days prior to the research study, except as explicitly approved by the Principal Investigator.
Meets current or lifetime DSM-5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder or has a first-degree family history of these disorders, this includes a history of hallucinogen-persistent perception disorder (HPPD)
Meets current DSM-5 criteria for bipolar disorder
Meets current DSM-5 criteria for severe Major Depressive Disorder (mild and moderate MDD as well as in stable remission are allowed if no suicidal risk and no ongoing antidepressant therapy).
Current or past significant trauma exposure with elevated Post-Traumatic Stress symptoms at the discretion of the PI.
Presence of any another psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.
Current or past month active suicidal ideations or lifetime history of serious suicidal attempt.
Has evidence of significant hepatocellular injury as evidenced by elevated bilirubin levels (greater than 1.3), or, pulmonary (e.g., COPD), endocrine, cardiovascular, renal (creatinine clearance less than or equal to 60ml/min) or gastrointestinal disease (e.g., Crohn's disease), or current HIV infection, and/or clinically significant levels (over 3.5x upper limit of normal) of aspartate aminotransferase (AST), and serumalanine aminotransferase (ALT). Patients with documented Gilbert's syndrome will be included regardless of bilirubin levels.
History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes and/or associated with skull fracture or intracranial bleeding or abnormal MRI.
Seizure disorder or history of seizures not related to drug or alcohol withdrawal (excluding childhood febrile seizure).
Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). An x-ray may be obtained to determine eligibility.
Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes.
Non-removable skin patches, at discretion of PI.
Has received medication that could interact adversely with psilocybin within the time of administration of study agent based on the Medical Director's guidance.
Needs treatment with any psychoactive (e.g., anti-depressants) medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
\*Have the following cardiovascular conditions:
\*At Screening or Baseline have elevated blood pressure as defined as:
What this trial measures
- Brain measure of GO domainOne week pre dose and one week post dose
Using fMRI, Investigators will measure the brain response to 500ms evocative cues and 6 second drug-related videos that trigger drug desire
- Behavioral measure of GO domainOne week pre dose and one week post dose
Using a the Affect Bias behavioral task, Investigators will measure the affective bias to opioid and other evocative visual cues.