CClinicalTrials.gg
WithdrawnNCT04771689Updated Jan 15, 2026

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

A Phase 4 interventional study of Buprenorphine/Naloxone in Post-operative Pain, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment

Why this study was withdrawn
lack of funding
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Post-operative Pain

Keywords

  • pain
  • pain management
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

Browse Pain, Postoperative studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • No intervention
    Standard Medication Regiment

    Subjects will take conventional intravenous or oral opioid management.

Interventions

  • DrugBuprenorphine/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.

    Also known as: Suboxone

06

What researchers measure

Primary outcomes

  1. Postoperative Pain Scores

    To examine changes in pain scores daily from the day of surgery to the hospital discharge day.

    Time frame: through study completion, an average of 6 days

  2. Postoperative Opioid Consumption

    To compare opioid consumption after surgery between the buprenorphine/naloxone group and the standard medication regiment group.

    Time frame: through study completion, an average of 6 days

  3. Length of Hospital Stay

    To compare the length of hospital stay after surgery between the buprenorphine/naloxone group and the standard medication regiment group.

    Time frame: through study completion, an average of 6 days

07

Study locations

1 site
  • Karina de Sousa
    Boston, Massachusetts 02114, United States
08

References and documents

Individual participant data

Plan to share: Yes — Deidentified data may be shared with other researchers in the future.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04771689
Lead sponsor
Massachusetts General Hospital
Responsible party
Yi Zhang, MD (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Feb 25, 2021
Start date
Jul 1, 2022 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jan 15, 2026

Study contacts

Yi Zhang, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion