This Phase I/Phase II interventional trial (n=60) aims to evaluate Ketamine Assisted Psychotherapy (KAP) as an adjunct to the Mindfulness-Oriented Recovery Enhancement (MORE) intervention for Opioid Use Disorder (OUD).
Stage 1 randomised, parallel-group trial comparing MORE combined with two ketamine-assisted psychotherapy sessions (MORE+KAP) versus MORE alone in patients receiving medications for OUD (e.g., buprenorphine).
MORE+KAP participants receive two intramuscular ketamine sessions (0.5–1.5 mg/kg) alongside the 8-week MORE programme; primary outcomes assess preliminary efficacy of KAP as an adjunct to MORE and secondary aims examine psychobiological mediators.
8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine-assisted psychotherapy sessions
0.5–1.5 mg/kg IM across two sessions
8 weeks of Mindfulness-Oriented Recovery Enhancement (behavioral comparator)
Mindfulness-Oriented Recovery Enhancement behavioural intervention; participants remain on MOUD (e.g., buprenorphine)