Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder (BIPOD-In)

This double-blind, controlled trial (n=90) will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to standard-of-care buprenorphine treatment for opioid use disorder (OUD). Conducted by Johns Hopkins University, the study aims to determine the effects of adjunctive psilocybin on longitudinal outcomes including opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

The trial involves a brief inpatient phase for buprenorphine induction and experimental psilocybin administration, followed by an 8-week outpatient phase with standard buprenorphine maintenance and experimental follow-up meetings, and concluding with long-term follow-up sessions for four months. Participants will undergo preparatory sessions before receiving either a very low (1 mg) or a single high (30 mg) oral dose of psilocybin in a supportive setting. The outpatient phase involves monitoring for adverse events, clinical status, treatment adherence, and weekly buprenorphine supply.

The study employs a Bayesian sequential methodology, with a maximum sample size of 90 participants. Bayes factors will be calculated at intervals, starting from 20 participants, to assess the evidence for both null and experimental hypotheses. This allows for potential early stopping for efficacy or futility based on predetermined thresholds. The primary outcome is opioid abstinence at 8 weeks. The trial is expected to commence in December 2023 and complete by July 2025. The study is currently recruiting participants aged 21-70 years, with specific inclusion and exclusion criteria focusing on health condition, medication usage, and risk factors.

Trial Details

This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

Trial Number NCT06005662

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