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

Withdrawn before enrolling · Phase 4

Conditions studied: Post-operative Pain

In brief

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

Key facts

Study ID

NCT04771689

Run by

Massachusetts General Hospital

People needed

0

Starts

2022-07-01

Expected to finish

2025-12-01

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 18 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

Where it is running

• Karina de Sousa — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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