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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06089707
Phase
PHASE3
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Naloxone Nasal Spray — DRUG
    IN naloxone will be administered to participants, after which a single dose of buprenorphine will be given to participants

Study Details

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.

Key Dates

Start date
Jan 9, 2024
Status verified
Jan 2025
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 4mg buprenorphine
    4mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.
  • Experimental: 8mg buprenorphine
    8mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.
  • Experimental: 16mg buprenorphine
    16mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.
  • Experimental: 24mg buprenorphine
    24mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.

Primary Outcome Measure

Peak opioid withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS) [ Time Frame: After administration of first dose of buprenorphine up to 8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21224
Cecilia Bergeria, PhD
[email protected]
410-550-1979
Anjalee Sharma, PhD
[email protected]

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By research site
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