Open-label single-group Phase I study (n=10) assessing safety of two oral psilocybin doses added to a stable buprenorphine-naloxone regimen in adults with opioid use disorder.
Open-label single-group pilot testing two oral psilocybin doses administered ~4 weeks apart to participants with OUD maintained on buprenorphine-naloxone; dosing occurs in capsules with two trained facilitators present.
Each dosing day includes at least 6 hours of preparatory counselling, approximately 8 hours of acute observation in the dosing room followed by overnight hospital observation, and an integration session with a psychologist prior to discharge.
Primary outcome is safety of concurrent psilocybin and buprenorphine-naloxone assessed by physiological measures (ECG, respiratory rate, BP, temperature, SpO2) and clinical/self-report instruments including COWS and opioid craving measures; secondary aims examine effects on buprenorphine effectiveness and self-efficacy/quality of life.
Open-label single-group: two oral psilocybin doses (~4 weeks apart) with facilitated counselling and overnight observation.
Oral capsules; dosing attended by two trained facilitators; open-label