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Painkiller study pulled before it even started

NCT ID NCT04771689

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 see if a tiny dose of buprenorphine/naloxone (a medicine used for opioid addiction) could help control pain after surgery in people who already take strong painkillers. It was designed for adults having orthopedic or general surgery. However, the study was withdrawn before any participants were enrolled, so no results are available.

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

Jul 2022

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 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. Opioid tolerance, defined as the daily use of greater than or equal to 60mg of oral morphine or an equianalgesic dose of any other opioid for more than 7 days immediately prior to the surgery 2. Undergoing orthopedic or general surgery 3. 18 years of age or older 4. Willing and able to adhere to the study protocol and follow-up schedule 5. Able to provide written informed consent to participate in the clinical trial 6. If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study Exclusion Criteria: 1. Buprenorphine or buprenorphine/naloxone use in the last two weeks 2. Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia 3. Patients receiving postoperative ketamine or lidocaine boluses or infusions 4. Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control 5. Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment 6. Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function 7. Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx 8. Positive pregnancy test for women of childbearing potential 9. Known allergy or sensitivity to bup/nx 10. Anticipation that the subject may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion 11. Current participation in additional pharmacologic research study 12. Active suicidal ideation as determined by PI or study clinician

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Conditions

The condition(s) this trial relates to.

agnosia Pain Pain, Postoperative

As listed by the trial registrant

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

Post operative pain

Contacts and locations

Locations

  • Karina de Sousa

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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