Phase 1 Study of Psilocybin Safety and Effects in Adults with Opioid Use Disorder on BuprenorphineNaloxone

What this Trial Is About

Researchers are investigating the safety and effects of adding psilocybin, taken orally in two doses about four weeks apart, to adults with opioid use disorder OUD who are maintained on a stable daily dose of buprenorphine-naloxone. This phase 1 clinical trial aims to assess adverse events linked to this combination and evaluate how psilocybin influences the effectiveness of buprenorphine-naloxone therapy, as well as the impact of concurrent buprenorphine-naloxone use on psilocybins effects. The study also describes changes in self-efficacy, quality of life, and pain. Participants begin by initiating and stabilizing buprenorphine-naloxone treatment under medical supervision. After psychological screening and at least six hours of preparatory counseling, participants receive the first oral psilocybin dose in a clinical research facility attended by two trained facilitators. They are observed for eight hours in the dosing room, then stay overnight in a hospital unit with a psychologist integration session before discharge. Approximately four weeks later, a second psilocybin dose is administered with the same observation and care. Participants who decline the second dose still complete follow-up assessments. During the study, participants undergo physiological monitoring including ECG, respiratory rate, blood pressure, body temperature, and oxygen saturation, along with clinical and self-report assessments such as the Clinical Opiate Withdrawal Scale, Opioid Craving Scale, and Timeline Follow-Back for opioid use. Safety is primarily measured by adverse event incidence and severity at one and five weeks post-dose. Secondary measures track opioid craving and use up to nine weeks. The entire participation period extends through post-dose follow-up to monitor safety and treatment effects.

Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine