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NCT06796062 · ClinicalTrials.gov registry record · Phase 2
Psilocybin for Opioid Use Disorder (OUD)
A Phase 2 study of Opioid Use Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 480
- Enrollment target
- 5
- Study locations
NCT06796062 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 480 participants, below the 4,654-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (90% lower). The trial reports 5 study locations across 2 states.
The verdict
NCT06796062, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 480 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,654-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (90% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
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.
NCT06796062 reports 5 study locations spanning 2 distinct geographic areas - top geographies include New York, New Mexico.
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.
What interventions are being tested in trial NCT06796062?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT06796062?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.