Actively Recruiting
Psilocybin for Opioid Use Disorder (OUD)
Led by NYU Langone Health · Updated on 2026-01-23
480
Participants Needed
5
Research Sites
163 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who continue to use illicit opioids in spite of adherence to standard-of-care treatment with methadone. Up to 480 participations will be consented to yield 240 randomized participants. This study is part of the NIH HEAL Initiative (https://heal.nih.gov/). In Stage 1, subjects will be randomly assigned to one of three groups: psilocybin 30 mg (high dose), psilocybin 20 mg (medium dose), and psilocybin 1 mg (control condition). By the end of Stage 1, an interim statistical analysis will be performed. The study will proceed to Stage 2 if at least one of the active dosages of psilocybin demonstrates 1) acceptable safety, based on analysis of safety data from Stage 1; and 2) conditional power of at least 25%, based on effect size estimates for the primary opioid use outcome (weeks of biologically-verified abstinence during 24 weeks of follow-up). Using a priori decision rules, the interim analysis will determine which of the active treatment groups (30 mg, 20 mg, or both) will be retained in Stage 2 of the trial. Stage 2 will continue the study, using the same treatment and assessment protocols, but retaining only the active dosage or dosages with a high probability of demonstrating efficacy relative to the psilocybin 1 mg control condition. The primary aims are to 1) Evaluate safety and efficacy outcomes in Stage 1 subjects in order to optimize design of the Stage 2, 2) Determine whether treatment with a single high (30 mg) or medium (20 mg) dose of psilocybin improves OUD treatment outcomes, relative to psilocybin 1 mg (control condition), in patients who continue to use illicit opioids despite adherence to methadone treatment, 3) Evaluate the effects of high-dose psilocybin and medium dose psilocybin on self-reported OUD-related neuropsychopathology, and 4) Identify likely responders to psilocybin treatment by using machine learning to model post-treatment OUD outcomes, based on pretreatment characteristics including all relevant clinical data, evaluations, and questionnaires.
CONDITIONS
Official Title
Psilocybin for Opioid Use Disorder (OUD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give voluntary informed consent
- Breath alcohol concentration at or below 0.01% at screening and baseline
- Able to read, speak, and understand English
- Between 18 and 65 years old at screening
- Diagnosed with Opioid Use Disorder using MINI evaluation
- Want to stop using illicit opioids
- In treatment at a participating Opioid Treatment Program for at least 6 months
- Currently prescribed methadone dose of at least 60 mg per day
- Methadone dose changed by no more than 20 mg in past month
- Taken methadone at least 25 of the last 30 days
- At least one urine drug screen positive for non-prescribed opioids in past 30 days
- Use opioids by insufflation, injection, or smoking
- Able and willing to follow all study requirements and visits
- Able to provide at least one negative drug screen for illicit opioids, cocaine, and stimulants during screening
- Agree to avoid non-prescribed psychotropic substances or illicit drugs for 72 hours before dosing, with some exceptions
- Agree to avoid non-prescription medications and supplements for 1 week before dosing unless approved
- Able to swallow capsules
- Agree to practice effective contraception as specified
- Have a family member or friend to assist with transportation and daily activities after dosing
- Able to provide adequate contact information
You will not qualify if you...
- Medical conditions that prevent safe participation, including seizure disorder, severe liver impairment, cardiovascular disease, uncontrolled high blood pressure, serious ECG abnormalities, hyperthyroidism, insulin-dependent diabetes, or other conditions judged unsafe
- DSM-5 psychiatric disorders such as schizophrenia spectrum, bipolar disorder, severe major depression, alcohol use disorder, or more than mild opioid withdrawal
- Active suicidal thoughts with intent or suicide attempt within past 12 months
- Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1
- History of hallucinogen use disorder or persisting perception disorder
- Hallucinogen use within past year
- More than 25 lifetime uses of classic psychedelics
- Currently incarcerated or pending legal actions preventing study participation
- Taking prohibited medications or supplements that have not been stopped as required
- Known allergy or hypersensitivity to psilocybin or study materials
- Allergy or contraindication preventing safe treatment of acute symptoms during dosing session
- Any other medical, psychiatric, or social condition likely to interfere with study adherence or safety as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Duke City Recovery Toolbox
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
2
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
3
StartCare
Brooklyn, New York, United States, 11206
Actively Recruiting
4
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
5
VIP Community Services, Inc
The Bronx, New York, United States, 10457
Actively Recruiting
Research Team
M
Michael Bogenschutz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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