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Psilocybin for Opioid Use Disorder (OUD)
NCT06796062 · View on ClinicalTrials.gov ↗
Study Summary
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 neuropsychopathol
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (5)
New York
- StartCare — Brooklyn
- NYU Langone Health — New York
- VIP Community Services, Inc — The Bronx
New Mexico
- Duke City Recovery Toolbox — Albuquerque
- University of New Mexico — Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2025-12-17 |
| Est. Completion | 2029-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06796062
The ClinicalTrials.gov registry entry for NCT06796062 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention — of which Psilocybin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06796062 reports 5 study locations spanning 2 distinct geographic areas — top geographies include New York, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06796062 about?
NCT06796062 is a clinical study titled "Psilocybin for Opioid Use Disorder (OUD)". 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-car...
What is the current status of trial NCT06796062?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 480 participants. The study started on 2025-12-17. Estimated completion is 2029-02.
What conditions does trial NCT06796062 study?
This clinical trial studies the following conditions: Opioid Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06796062?
The interventions under investigation include: Psilocybin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06796062?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06796062 being conducted?
This trial has 5 study locations across New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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