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Study of Naloxone Before Buprenorphine for Fentanyl Use

This study is looking at a new way to help people with Opioid Use Disorder who use fentanyl start buprenorphine treatment. Fentanyl makes it harder to start buprenorphine, often causing uncomfortable withdrawal. Researchers are testing if giving naloxone nasal spray (used to reverse overdose) before buprenorphine can make the transition safer and faster. They want to see if this method reduces withdrawal symptoms, is acceptable to participants, and helps people reach a stable buprenorphine dose more quickly. To join, you must be 18 or older, speak English, be medically cleared, and have fentanyl in your urine. The study is currently unclear on its recruitment status and plans to enroll 3 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 3 participants.
What's involved
You would provide a urine sample that tests positive for fentanyl. You would receive naloxone nasal spray, followed by a single dose of buprenorphine.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure peak opioid withdrawal for up to 8 hours after the first buprenorphine dose. They will also check self-report acceptability at 3 days and how long it takes to reach 8mg of buprenorphine, up to 24 hours after the initial dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06089707

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~3 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Naloxone Nasal Spray

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak opioid withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)
Measured over After administration of first dose of buprenorphine up to 8 hours
+2 more outcomes measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Cecilia Bergeria, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

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

    Opioid withdrawal severity will be measured with the Subjective Opiate Withdrawal Scale (SOWS) and will be computed as the peak total SOWS score in the 8 hours after buprenorphine administration. The SOWS consists of 16 opioid withdrawal symptoms that are assessed for severity on a scale from 0-4 ("Not at all" to "Extremely"). Total scores range from 0-64 where a score between 0-10 is considered mild, between 11-20 is considered moderate, and greater than 21 is considered severe.

  • Self-report acceptability3 days

    Acceptability will be measured by an acceptability questionnaire designed by the research team. Items from the questionnaire will be computed as the average acceptability score. Scores range from 0-10, where 0 reflects no acceptability and 10 reflects high acceptability.

  • Length of time (hours) for participants to reach 8mg of buprenorphineAfter initial buprenorphine dose up to 24 hours

    Time between initial buprenorphine dose and time reaching a dose of at least 8mg buprenorphine dosage will be measured to understand how long it takes patients to tolerably receive the minimum maintenance dose of 8mg