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New study tests best ways to get opioid treatment to those who need it

NCT ID NCT04991974

Disease control Sponsor: Friends Research Institute, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at different ways to help people with opioid use disorder start treatment. It compared usual care, patient navigation (help from a guide), and patient navigation plus starting buprenorphine right away. The goal was to see which approach gets more people into treatment within one month. The study involved 373 adults who had used opioids recently and were willing to try buprenorphine.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

373 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2026

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: 1. Age 18 or older 2. Opioid use in the past 30 days 3. DSM-5 diagnostic criteria for OUD with physiological dependence 4. Willing to try buprenorphine treatment. Exclusion Criteria: 1. current enrollment in OUD treatment with buprenorphine, methadone, or extended-release naltrexone 2. clinical contraindication with buprenorphine (e.g., allergy to buprenorphine or naloxone, chronic pain management with opioid agonists) 3. regular use of illicit long-acting opioid agonists (e.g., methadone; due to potential challenges with dose induction) 4. heavy alcohol use that, in the judgement of the prescribing provider, raises a safety concern that precludes eligibility for buprenorphine induction 5. high dose or intravenous benzodiazepine misuse 6. pregnancy (due to special needs; will be treated outside of the study) 7. unstable medical or psychiatric illness (e.g., psychosis or active suicidal ideation) 8. inability to provide informed consent (e.g., failure to pass consent quiz)

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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

  • Baltimore City Health Department Sexual Health Clinics

    Baltimore, Maryland, 21202, United States

  • Friends Research Institute

    Baltimore, Maryland, 21201, United States

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