Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder (BIPOD-In)
Double-blind, controlled trial (n=90) comparing a single high-dose psilocybin session (30 mg) versus a very low dose (1 mg) as adjunctive therapy to standard buprenorphine treatment for OUD.
Details
Randomised, quadruple-blind, parallel-group trial enrolling up to 90 participants with opioid use disorder undergoing standard buprenorphine induction; participants receive either 30 mg or 1 mg oral psilocybin during a brief inpatient admission.
Primary outcome is opioid abstinence at 8 weeks; additional outcomes include buprenorphine adherence, quality of life, craving, tobacco use, and retention. The design uses Bayesian sequential monitoring with planned interim analyses to allow early stopping for efficacy or futility.
Study includes a 6-8 day inpatient induction and dosing phase with preparatory sessions (2-3), followed by an 8-week outpatient maintenance and longer-term follow-up to 4 months.