NIH-funded research R01 grant

Psilocybin and opioid use disorder: a crossover trial to understand how psilocybin might help reduce relapse risk

Official title: Mechanistic Evaluation of Psilocybin in Opioid Use Disorder: A Randomized, Double-Blind, Active-Placebo-Controlled Crossover Trial with Pharmacokinetic/Pharmacodynamic Modeling

Funded at Johns Hopkins University · NIH-11425436 · Data updated 2026-11-12

A Johns Hopkins-led study will test whether a single high dose of psilocybin can change withdrawal and craving in adults with opioid use disorder, using a careful crossover design to compare two doses.

More Opioid Use research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionJohns Hopkins University
NIH-funded
Lab location1 site (Baltimore, United States)
Project startSeptember 30, 2026
Project endJuly 31, 2031
Funding year2026
Award (this year)$683,851
NIH project number1R01DA066503-01
Project IDNIH-11425436 on NIH RePORTER

Who could benefit from this research

Could help

Adults 21+ with opioid use disorder who are not currently seeking treatment and are willing to participate in a tightly monitored crossover study.

Less likely to help

People who are not suitable for psychedelic studies or who do not have opioid use disorder are unlikely to benefit.

What this research studies

If you have opioid use disorder, this study will involve two sessions where participants receive psilocybin or a low-dose comparison in random order, with a washout period between sessions. Researchers will monitor physiological responses and drug-related cravings, and use special tasks to see how participants value opioids during and after the dose. The goal is to understand how psilocybin affects brain and body processes that contribute to relapse, while keeping safety first. Participants will be closely watched and assessment measures will track withdrawal symptoms, craving, and autonomic responses over several days.

Why it matters

Potential benefit: If successful, findings could inform future treatments that reduce relapse risk for people with opioid use disorder.

How similar studies have gone: Prior research in humans suggests serotonergic mechanisms may influence addiction-related processes, but this study is among the more rigorous tests in OUD with pharmacologic and behavioral endpoints.

Where this research is happening

  • Johns Hopkins University
    Baltimore, United States
    Active

Researchers

  • Principal investigator: Martinez, Suky — Johns Hopkins University
  • Study coordinator: Martinez, Suky

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.