Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
Johns Hopkins University
Summary
The opioid overdose epidemic has persisted for several decades and is now further complicated by the permeation of fentanyl into the illicit opioid supply. While the effectiveness of medications to treat opioid use disorder (MOUD) have been well documented in the literature, the addition of fentanyl to the drug supply has complicated the initiation of MOUD, especially buprenorphine. Naloxone, an opioid antagonist, is currently utilized to reverse opioid overdose by displacing less-competitive ligands which bind at the mu-opioid receptor. Because induction to buprenorphine in the age of fentanyl is uncomfortable and can take several days to stabilize a patient on a therapeutic dose, the use of naloxone prior to buprenorphine can aid in a safe and rapid transition to buprenorphine treatment, without the effect of unintended prolonged precipitated withdrawal which can occur following the displacement of fentanyl by buprenorphine on the mu-opioid receptor. Therefore, this project will assess feasibility and acceptability of naloxone-facilitated buprenorphine initiation using a single-ascending dose design. The investigators will examine whether a single dose of buprenorphine is tolerated following administration of naloxone among a small group of individuals. If the dose is tolerated, the investigators will administer a larger dose among another small group of individuals. The investigators will examine the tolerability of up to 4 doses of buprenorphine following naloxone. This buprenorphine induction method has been characterized in case studies but it has not been evaluated in an empirical, systematic way in a controlled setting. This study will take place within an residential facility at Johns Hopkins Bayview Medical Campus, and will have immediate, real-world applicability in establishing a rapid, safe, and effective option to transition people with chronic fentanyl use to buprenorphine treatment.
Description
Emergent data suggest that individuals with fentanyl use experience prolonged, uncomfortable buprenorphine inductions that can commonly result in instances of unintended precipitated withdrawal. Buprenorphine induction in the fentanyl era can take multiple days, which is time intensive and increases the risk for treatment attrition. Novel methods that transition patients quickly and safely from fentanyl to buprenorphine are needed. The proposed project will evaluate the feasibility and acceptability of naloxone-facilitated buprenorphine inductions among individuals with recent fentanyl exposu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 years or older * Speak fluent English * Medically cleared to take study medication * Willing to comply with the study protocol * Provides urine sample that tests positive for fentanyl * Current moderate to severe opioid use disorder Exclusion Criteria: * Significant cognitive impairment resulting in inability to provide informed consent (e.g., severe dementia or intellectual disability) * Unable to read or understand study questions with assistance from the research staff * Medical symptoms interfering with their ability to answer study questions * Psychiatric sympt…
Interventions
- DrugNaloxone Nasal Spray
IN naloxone will be administered to participants, after which a single dose of buprenorphine will be given to participants
Location
- Johns Hopkins School of MedicineBaltimore, Maryland