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New injection method aims to make opioid addiction treatment easier to start

NCT ID NCT06441604

Disease control Sponsor: Brigham and Women's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 4 times

Summary

This study tests whether a long-acting buprenorphine injection can be used to start treatment for opioid use disorder without causing severe withdrawal. Thirty adults with opioid use disorder will stay in a hospital for three days, receive fentanyl to prevent withdrawal, and then get one injection of extended-release buprenorphine at different doses. Researchers will monitor safety and measure drug levels in the blood.

What this could mean

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

Active substance
extended-release buprenorphine injection
What this could lead to
If successful, this could offer a safer, more comfortable way to start buprenorphine treatment for opioid use disorder, reducing the risk of severe withdrawal symptoms.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply broadly. There is a risk of precipitated withdrawal despite the use of fentanyl.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

8 people

The number who actually took part.

Started

Oct 2025

Expected to finish

Jan 2027

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: * English speaking adults aged 18 and above. * diagnosis of opioid use disorder. * Self-reporting use of illicit opioids in \>21 days in the prior 30 days. * Provide urine toxicology testing positive for fentanyl at baseline. Exclusion Criteria: * Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone. * Received buprenorphine or methadone treatment in prior 30 days. * Current diagnosis of alcohol or sedative/hypnotic use disorder. * Positive urine drug screen for benzodiazepines, alcohol and or methadone. * Physical dependence on alcohol or sedative/hypnotics. * Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent. * Have a history or diagnosis of Intracranial mass/bleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, heart failure. * Recent (within 6 months) head trauma, stroke, or myocardial infarction * Requiring treatment with opioids for acute or chronic pain. * History of hypersensitivity or allergy to buprenorphine or fentanyl. * Pregnant or breastfeeding. * Liver function test greater than 3 times upper normal limit. * Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.

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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

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02118-5605, United States

More trials for these conditions

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