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New approach lets patients start addiction treatment without first going through withdrawal

NCT ID NCT05118204

Symptom relief Sponsor: Montefiore Medical Center 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new method for starting buprenorphine (a medication for opioid use disorder) in hospitalized adults who also have chronic pain. Instead of requiring patients to stop all other opioids and go through withdrawal first, the new method starts with very low doses of buprenorphine while continuing other opioids. The study enrolled 23 adults and compared this microdose approach to the standard method, looking at how many patients successfully started buprenorphine treatment.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

23 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 2025

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: * Age \> 18 years * Opioid misuse or OUD * Chronic pain * Currently taking opioids * Fluency in English or Spanish * Planned hospitalization for ≥ 48 hours Exclusion Criteria: * Current OUD treatment (BUP, methadone, naltrexone) * Severe alcohol or benzodiazepine use disorder * Hypersensitivity to BUP or naloxone * Pain due to malignancy * Severe untreated mental illness (suicidality, psychosis) * Pregnancy * Unable to consent due to pain or cognitive impairment

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome opiate dependence substance-related disorder

As listed by the trial registrant

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

Chronic pain Opioid-use disorder Substance use disorders

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

More trials for these conditions

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