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Can you safely stop opioid addiction meds? small study explores the exit strategy

NCT ID NCT05878210

Knowledge-focused Sponsor: Indivior 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 12 people with opioid use disorder who had been stable on SUBLOCADE injections for at least 9 months. Researchers wanted to see if they could successfully stop the medication without relapsing or restarting long-term treatment. The goal was to understand the withdrawal experience and how well people manage after stopping.

What this could mean

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

Active substance
SUBLOCADE (buprenorphine extended-release injection)
What this could lead to
If successful, this could help doctors and patients understand the best way to safely stop long-term opioid addiction medication without relapse.
What could go wrong
This is a very small, completed observational study with only 12 participants, so results may not apply to everyone. It does not test a new 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.

Participants

12 people

The number who actually took part.

Started

Nov 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and discontinue SUBLOCADE treatment.

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 Participants must meet all of the following criteria: * The participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop MOUD treatment, and the participant meets the following criteria: * Has been treated with at least 12 injections of SUBLOCADE. * In the opinion of the investigator, has had their OUD symptoms (ie, overdose, illicit/nonmedical use, withdrawal) controlled for at least 9 months. * In the opinion of the investigator, has had any other substance use disorder (excluding alcohol, nicotine, or cannabis) symptoms controlled for at least 9 months. * Is willing to complete the Baseline Visit 4 to 8 weeks after the last dose of SUBLOCADE. * Has signed the ICF and is 18 years of age or older. * Is not currently using opioids to treat a diagnosis other than OUD.

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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

  • Comprehensive Addiction Medicine

    Portland, Maine, 04102, United States

  • Savera Medical Centre

    Edmonton, Alberta, T6E6T9, Canada

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