RECRUITINGPhase 3INTERVENTIONAL

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Significant cognitive impairment resulting in inability to provide willing to sign a consent form (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 symptoms interfering with their ability to answer survey questions - Currently enrolled and taking medications for OUD - Pregnant or Breastfeeding - Taking medication contraindicated with study medication - Deemed by the principal investigator or medical team to not be a good fit for the study protocol. - Current or history of hypo/hypertension (i.e., no less than 90/60, no greater than 140/90) or adverse cardiovascular event in the past three years (e.g. significant cardiac arrhythmia, myocardiac infarction, endocarditis). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 symptoms interfering with their ability to answer survey questions * Currently enrolled and taking medications for OUD * Pregnant or Breastfeeding * Taking medication contraindicated with study medication * Deemed by the principal investigator or medical team to not be a good fit for the study protocol. * Current or history of hypo/hypertension (i.e., no less than 90/60, no greater than 140/90) or adverse cardiovascular event in the past three years (e.g. significant cardiac arrhythmia, myocardiac infarction, endocarditis).

Treatments Being Tested

DRUG

Naloxone Nasal Spray

IN naloxone will be administered to participants, after which a single dose of buprenorphine will be given to participants

Locations (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, United States