Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms

NCT04091009 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2019P001092
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain. The investigators want to compare how well pain is managed after surgery ("post-op") in two groups: The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery. The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, participants will be put back on their full dose of buprenorphine. The investigators also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.

Conditions

Opioid-use Disorder; Opioid Use Disorder, Mild

Outcome Measures

Primary Outcomes (1)

• Pain scores at 24 hours post-operative procedure

  Average pain scores at 24 hours post-op

  24 hours

Study Arms (2)

Continue Group

ACTIVE COMPARATOR

Those who continue taking their standard dose of buprenorphine before, during and after surgery.

Drug: Buprenorphine/naloxone

Reduce Group

ACTIVE COMPARATOR

Those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, you will be put back on your full dose of buprenorphine.

Drug: Buprenorphine/naloxone

Interventions

Buprenorphine/naloxone DRUG

Participants will be prescribed 8mg buprenorphine daily from the day of surgery until transitioned back to their regular dose of buprenorphine when postoperative surgical pain has subsided

Continue Group; Reduce Group

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) health class I-III
• Currently taking buprenorphine or buprenorphine/naloxone daily at a dose of at least 16mg per day for at least the prior 30 days for treatment of Opioid Use Disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
• Scheduled for surgery at Massachusetts General Hospital where greater than 3/10 pain is expected on post-operative day 1

You may not qualify if:

• Participants unable to consent to the study
• Renal insufficency with a glomerular filtration rate \<30ml/min (participants would be unable to use ketorolac which is a part of the multimodal anesthetic plan)
• Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score \> 25 (participants would be unable to use Tylenol which is part of the multimodal anesthetic plan)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Opioid-Related Disorders; Lymphoma, Follicular

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune 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

• Zhang Yi, 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: September 13, 2019
• First Posted: September 16, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share