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Pain management study for opioid users on buprenorphine withdrawn before it began

NCT ID NCT04091009

Disease control Sponsor: Massachusetts General 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 aimed to compare two ways of managing pain after surgery in people taking buprenorphine for opioid use disorder. One group would continue their usual dose, while the other would receive a lower dose around the time of surgery. The goal was to see which approach better controls pain and reduces cravings or relapse. However, the study was withdrawn before any participants were enrolled.

What this could mean

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

Active substance
buprenorphine/naloxone
What this could lead to
If successful, this could help guide doctors on whether to lower or maintain buprenorphine doses during surgery to better manage pain and reduce relapse risk.
What could go wrong
The study was withdrawn before enrolling any participants, so no results are available. The approach may not work as hoped, and individual responses to dose changes can vary.

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.

Expected to start

Oct 2019

An estimate. Start dates often move.

Expected to finish

Dec 2025

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 to 65 years

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: * American Society of Anesthesiologists (ASA) health class I-III * Currently taking buprenorphine or buprenorphine/naloxone daily at a dose of at least 16mg per day for at least the prior 30 days for treatment of Opioid Use Disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria * Scheduled for surgery at Massachusetts General Hospital where greater than 3/10 pain is expected on post-operative day 1 Exclusion Criteria: * Participants unable to consent to the study * Renal insufficency with a glomerular filtration rate \<30ml/min (participants would be unable to use ketorolac which is a part of the multimodal anesthetic plan) * Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score \> 25 (participants would be unable to use Tylenol which is part of the multimodal anesthetic plan)

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Conditions

The condition(s) this trial relates to.

follicular lymphoma opiate dependence

As listed by the trial registrant

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

Opioid use disorder Opioid use disorder, mild

More trials for these conditions

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