Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
Trial Parameters
Brief Summary
Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects of psilocybin therapy. Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain.
Eligibility Criteria
Inclusion Criteria: * Aged 21 to 65 years * Able to read, speak, and understand spoken and written English * Diagnosis of moderate or severe opioid use disorder (OUD) * Current opioid misuse, with misuse occurring on at least 10 of the last 30 days (at least 5 of last 30 days if already on buprenorphine/naloxene. See exclusion #1). Misuse will be defined as either: 1. Use of illicit opioids, such as heroin or street fentanyl; or use of a prescription opioid (such as oxycodone, morphine, or hydrocodone) through a route (e.g. nasal, injected) other than FDA approved , and/or 2. Use of a prescription opioid for a purpose (e.g. intoxication, anxiety relief) other than that for which it was prescribed. * Able to achieve stable daily dose of a buprenorphine-naloxone formulation that controls opioid withdrawal symptoms * Persons of childbearing potential must agree to practice an effective means of contraception throughout their participation in the study, beginning at screening and throughou