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A nose spray before treatment: could naloxone speed up opioid recovery for fentanyl users?

NCT ID NCT06089707

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial tests whether giving naloxone — the opioid-overdose reversal drug — just before buprenorphine can help people who use fentanyl start addiction treatment more quickly and with less discomfort. The study enrolls a small group of adults with opioid use disorder who test positive for fentanyl. Researchers will measure withdrawal severity, how long it takes to reach a stable buprenorphine dose, and whether participants find the method acceptable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naloxone nasal spray followed by buprenorphine
What this could lead to
If this approach works, it could offer a faster, less uncomfortable way to start buprenorphine treatment for people dependent on fentanyl.
What could go wrong
This is a very small early-phase trial with only 3 participants, so results may not apply broadly. The method could still cause withdrawal symptoms or be poorly tolerated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use disorder

Contacts and locations

Locations

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.