NCT06796062 · NYU Langone Health
Psilocybin for Opioid Use Disorder (OUD)
What this study is about
This is a where neither patients nor doctors know which treatment is given, adaptive, 2-stage, multi-site, phase 2 randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Psilocybin
One capsule (1 mg, 20 mg, or 30 mg) administered once orally
Primary outcome measures
Stage 1: The number of weeks during the 24 week follow-up period with no illicit opioid use
Time frame: Up to 24 weeks
Subject reports no illicit opioid use and provides a urine drug screen (UDS) negative for all classes of opioids other than methadone or other legally prescribed opioids.
Stage 1: Number of adverse events
Time frame: Up to 24 weeks
Stage 1: Change in QTc during drug administration session
Time frame: Up to 24 weeks
Stage 2: The number of weeks during the 24 week follow-up period with no illicit opioid use
Time frame: Up to 24 weeks
Stage 2: Number of adverse events
Time frame: Up to 24 weeks
Stage 2: Change in QTc during drug administration session
Time frame: Up to 24 weeks
Stage 2: Total score on the Penn Craving Scale for Opioids
Time frame: Up to 24 weeks
The Penn Alcohol Craving Scale (PACS) is a 5-item questionnaire that measures an individual's craving to drink alcohol in the past week. The self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Low score (below 15) indicates minimal to no reported alcohol craving. Moderate score (15-20) suggests a moderate level of alcohol craving. High score (above 20) represents a high level of alcohol craving, potentially warranting further assessment and treatment
Stage 2: Score on the Negative Affect subscale of the Positive and Negative Affect Scale
Time frame: Up to 24 weeks
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point verbal frequency scale of 1 (not at all) to 5 (very much). Scores range from 10 - 50 for both sets of items. For the total negative score, a lower score indicates less of a negative affect.
Stage 2: Total score on the 20-item version of the Short Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (UPPS-P) Impulsive Behavior Scale (SUPPS-P)
Time frame: Up to 24 weeks
The 20-item version of the UPPS-P Impulsive Behavior Scale, also known as the SUPPS-P, is a shortened questionnaire that assesses five different dimensions of impulsivity: negative urgency, positive urgency, lack of perseverance, lack of premeditation, and sensation seeking; with four items dedicated to each dimension, totaling 20 questions in total. Responses are rated on a Likert scale (e.g., strongly disagree to strongly agree), with higher scores generally indicating a greater tendency towards impulsive behavior.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Are able to provide voluntary informed consent. 2. Have a breath alcohol concentration ≤ 0.01% at Screening Part 2, as determined by a breath alcohol reading from a calibrated breath alcohol sensor. (Note: this criterion may be re-evaluated within the 30-day screening period. This criterion will also be reassessed at Baseline and on Day 0 (prior to IP administration). Those not meeting the criterion may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator). 3. Are able to read, speak, and understand English, as documented during the informed consent process. a. Non-English speaking subjects will be excluded because the study is using only validated English-language versions of of assessment instruments. 4. Are 18 to 65 years old, inclusive, at Screening Part 2. 5. Have Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM 5) diagnosis of OUD, based on an evaluation p
Where
- Albuquerque, New Mexico
- Brooklyn, New York
- New York, New York
- The Bronx, New York
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations