Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine

Launched by UNIVERSITY OF WISCONSIN, MADISON · Nov 8, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a substance called psilocybin when added to a treatment for opioid use disorder (OUD) that includes buprenorphine-naloxone. The main goal is to understand if taking psilocybin alongside this treatment causes any side effects and how it might change how effective the buprenorphine-naloxone is for managing OUD. Additionally, the trial will look at how this combination impacts participants' sense of self-worth, quality of life, and any pain they might experience.

To be eligible for this trial, participants should be between 21 and 65 years old and have a diagnosis of moderate to severe opioid use disorder. They should also be currently misusing opioids, meaning they are using them in ways not approved by a doctor. Participants must be able to stick to study requirements, such as attending all visits and having a support person available during treatments. If you or someone you know is interested in this study, it's important to discuss any health conditions with a healthcare provider to see if this trial is a good fit.

Gender

ALL

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. Misuse will be defined as either:
• • 1. Use of illicit opioids, such as heroin or non-prescribed fentanyl; or use of an outpatient prescription opioid (such as oxycodone, morphine, or hydrocodone) through a route other than FDA approved (e.g. nasal, injected), and/or
• • 2. Use of a prescription opioid via a route (e.g. nasal, injected, chewed) or 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 throughout follow-up
• • Ability and willingness to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and evaluations
• • Healthy kidney function
• • Able to provide contact information for a local support person. This person must be available during both 24-hour treatment and observation periods, and willing to provide the participant social/emotional support the day after each treatment and as needed during the dosing day and/or overnight observation period.
• Exclusion Criteria:
• • Currently prescribed and has taken buprenorphine or buprenorphine formulation (e.g., Suboxone®) for over four weeks immediately prior to initial study contact
• • Currently receiving pharmacotherapy of any duration with methadone
• • Current participation in a drug treatment court program or other legal supervision. Individuals who are under legal supervision will be advised that participating in this study could potentially violate terms of probation, parole, or extended supervision. Contact information for the individual's community supervision officer must be collected to confirm whether study participation may impact the potential participant's status on probation or parole
• • Inadequately treated hypertension
• • Current acute coronary syndrome or angina
• • Evidence of ischemic disease, cardiac conduction defects, and/or ventricular arrhythmias on screening ECG
• • History of heart transplant
• • Current insulin dependence, due to Type I or Type II diabetes
• • Urine drug test containing non-prescribed drugs of abuse
• • Any finding(s), based on the screening process, that the PI feels makes the study unsuitable for the participant