Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
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.