Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients

January 13, 2026 updated by: Yi Zhang, MD, Massachusetts General Hospital

Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients

A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Karina de Sousa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Buprenorphine/Naloxone
Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed.
Drug: Buprenorphine/Naloxone
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for the length of their hospital stay, at least 6 days.
Other Names:
  • Suboxone
No Intervention: Standard Medication Regiment
Subjects will take conventional intravenous or oral opioid management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: through study completion, an average of 6 days
To examine changes in pain scores daily from the day of surgery to the hospital discharge day.
through study completion, an average of 6 days
Postoperative Opioid Consumption
Time Frame: through study completion, an average of 6 days
To compare opioid consumption after surgery between the buprenorphine/naloxone group and the standard medication regiment group.
through study completion, an average of 6 days
Length of Hospital Stay
Time Frame: through study completion, an average of 6 days
To compare the length of hospital stay after surgery between the buprenorphine/naloxone group and the standard medication regiment group.
through study completion, an average of 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Yi Zhang, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021P000553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data may be shared with other researchers in the future.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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