NYU's psilocybin trial for people on methadone opens at Brooklyn and Bronx treatment programs

What the trial is testing

The study (NCT06796062) is randomized and double-blind, and it runs in two stages. In stage 1, each participant is assigned to one of three groups and takes a single capsule in a supervised session, then stays at the facility for 8 hours. Per the registry, the trial gives psilocybin 30 mg, psilocybin 20 mg, or psilocybin 1 mg as the control. An interim analysis then decides which of the two higher amounts continue into stage 2, based on safety and on how likely each is to show a benefit.¹

Up to 480 people will be consented to reach 240 randomized participants. The main measure is the number of weeks, over 24 weeks of follow-up, in which a participant reports no illicit opioid use and gives a urine drug screen negative for opioids other than methadone or other prescribed opioids. The team also counts adverse events and tracks QTc, a heart-rhythm measure, during the session.¹

Who can take part

Participants must be 18 to 65, have opioid use disorder, want to stop using illicit opioids and have been in treatment at one of the participating opioid treatment programs for at least six months. They must still be using: at least one urine screen positive for non-prescribed opioids in the 30 days before screening. They also need a friend or relative who can help with transportation and daily tasks after the session.¹

Exclusions include any lifetime psychotic or bipolar disorder; a parent, sibling or child with schizophrenia, schizoaffective disorder or bipolar I; any hallucinogen use in the past year or more than 25 lifetime uses of classic psychedelics; alcohol use disorder; a suicide attempt in the past 12 months; and heart disease or uncontrolled high blood pressure. The registry adds that prescribed psychiatric medicines must not be stopped in order to qualify.¹

Who is paying for it

The National Institute on Drug Abuse is the trial's collaborator, and the study is part of the NIH HEAL Initiative.¹ NIH's grant database lists the award, UG3DA062088, to NYU School of Medicine: $3,244,725 in fiscal 2024 and $3,172,763 in fiscal 2025, with the current project period ending August 31, 2027.² In October 2024, B.More, a nonprofit drug developer working with the NYU team, described the grant as $3 million a year for five years, "dependent on progress during the first 2 years," and said it would supply the psilocybin and license the trial data.³

Why it matters in New York

Two of the trial's three city sites are community treatment programs rather than hospitals, and the registry requires participants to be in treatment at one of the participating opioid treatment programs, so people already in care at StartCare or VIP Community Services can ask about the study at the program where they get treatment.¹ It's one of 12 psilocybin and psilocin-analog studies recruiting at a New York site, by our count of the registry; our New York trials list has the others.

Psilocybin is a Schedule I drug under federal law, so outside approved research it can't be prescribed.⁴ Our guide to psilocybin therapy in NYC covers what is legal here today, and safety and help lists crisis lines. We found no NYU Langone announcement of the start; the registry record, last updated January 23, 2026, is the public record so far.¹