Psilocybin for Opioid Use Disorder

This study is testing psilocybin to see if it can help people with Opioid Use Disorder (OUD) who are still using illicit opioids even while on methadone treatment. We are looking at how different doses of psilocybin (1 mg, 20 mg, or 30 mg) affect opioid use. We will also be tracking any side effects and changes in heart rhythm. You might be able to join if you are between 18 and 65 years old. The study aims to enroll up to 480 participants, with 240 being randomly assigned to a treatment group. The current recruitment status is unclear.

Study design: This is a double-blind (meaning neither you nor your doctor will know which dose you receive), adaptive, two-stage, multi-site, randomized controlled trial. Up to 480 people will be considered, with 240 being randomly assigned to one of three psilocybin dose groups.
What's involved: You will receive one capsule of psilocybin orally. The study will track your progress for up to 24 weeks after this administration.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for up to 24 weeks after receiving the psilocybin capsule.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Psilocybin for Opioid Use Disorder (OUD)

Recruiting

PHASE2Ages 18–65InterventionalTreatment

NYU Langone Health

~480 participants

Updated 2026-01-23 on ClinicalTrials.gov

What's tested:Psilocybin

At a glance

Recruiting sites

5 of 5 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Stage 1: The number of weeks during the 24 week follow-up period with no illicit opioid use

Measured over Up to 24 weeks

+8 more outcomes measured

Conditions

Opioid Use Disorder

Where it's being run

5 sites across 2 states

New York3

New Mexico2

Study leadership

Michael Bogenschutz, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Michael Bogenschutz, MD

[email protected]

646-501-4026

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Do not have a uterus

Are postmenopausal (has had 12 months of natural amenorrhea with a matching clinical profile \[age, history of vasomotor symptoms\]) prior to Screening Part 2, or

Are surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) 2. Subjects who are able to become pregnant must:

Have a negative pregnancy test at Screening Part 2 (Reassessed at Day 0 (pre-IP administration);

Not be currently breastfeeding;

Not intend to become pregnant during participation in this study;

Agree to use a highly effective form of contraception from the time of the Screening Part 2 until 7 days after the IP Administration Session. Highly effective forms of contraception include: 1) Consistent and correct usage of established oral contraception; 2) Injected or implanted hormonal methods of contraception; 3) Established intrauterine device or intrauterine system; 4) Bilateral tubal ligation; 5) Intercourse with a partner who has undergone effective surgical sterilization, provided that partner is the sole sexual partner of the study subject; 6) Abstinence from penile/vaginal intercourse, if the Investigator determines that the subject can reliably adhere to the plan, based on evaluation of the social circumstances of the subject. 3. Agree not to donate or bank eggs from the time of Screening Part 2 until 7 days after the IP Administration Session. 4. Subjects who can emit sperm are defined as those who:

Have one or more testes and

Have not had a documented effective surgical sterilization procedure (e.g., vasectomy, radical prostatectomy). 5. Subjects who can emit sperm must:

Practice effective contraception from Screening Part 2 until 7 days after the IP Administration Session. Effective means forms of contraception include:

use condoms with spermicide if engaging in penile/vaginal intercourse;

abstain from penile/vaginal intercourse, if the Investigator determines that the subject can reliably adhere to the plan, based on evaluation of the social circumstances of the subject

Agree not to donate or bank sperm from the time of the Screening Part 2 until 7 days after the IP Administration Session 19. Have a family member or friend who can assist with transportation and activities of daily living after the IP Administration Session, as determined by self-report at Screening Part 2 and confirmed by direct communication between a member of the clinical support team and the support person prior to randomization. (Note: this criterion will be reassessed on Day 0. 20. Are able to provide adequate locator information. This criterion may be re-evaluated within the 30-day screening period.

What this trial measures

Stage 1: The number of weeks during the 24 week follow-up period with no illicit opioid useUp 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 eventsUp to 24 weeks
Stage 1: Change in QTc during drug administration sessionUp to 24 weeks
Stage 2: The number of weeks during the 24 week follow-up period with no illicit opioid useUp to 24 weeks
Stage 2: Number of adverse eventsUp to 24 weeks
Stage 2: Change in QTc during drug administration sessionUp to 24 weeks
Stage 2: Total score on the Penn Craving Scale for OpioidsUp 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 ScaleUp 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)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.

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