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

NCT04771689 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2021P000553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-operative Pain

Keywords

pain; pain management

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain Scores

  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

  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

  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

Study Arms (2)

Buprenorphine/Naloxone

ACTIVE COMPARATOR

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

Standard Medication Regiment

NO INTERVENTION

Subjects will take conventional intravenous or oral opioid management.

Interventions

Buprenorphine/Naloxone DRUG

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.

Also known as: Suboxone

Buprenorphine/Naloxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Undergoing orthopedic or general surgery
• years of age or older
• Willing and able to adhere to the study protocol and follow-up schedule
• Able to provide written informed consent to participate in the clinical trial
• If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study

You may not qualify if:

• Buprenorphine or buprenorphine/naloxone use in the last two weeks
• Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia
• Patients receiving postoperative ketamine or lidocaine boluses or infusions
• Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control
• Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment
• Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function
• Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx
• Positive pregnancy test for women of childbearing potential
• Known allergy or sensitivity to bup/nx
• 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
• Current participation in additional pharmacologic research study
• Active suicidal ideation as determined by PI or study clinician

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Karina de Sousa

Boston, Massachusetts, 02114, United States

Location

Related Links

• Massachusetts General Hospital Center for Translational Pain Research

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Yi Zhang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 25, 2021
• Study Start: July 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)