The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use

There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance Abuse and Mental Health Services Administration (SAMHSA). There is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. Preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (OUD) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. Since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.

Study Overview

• Status: Terminated
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Drug: Buprenorphine; Drug: Buprenorphine

Detailed Description

The purpose of this study is to investigate whether buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery. Adults scheduled for elective surgery who are taking ≥12mg buprenorphine for OUD treatment will be eligible for this study. Enrolled participants will be randomized to receive either a reduced analgesic dose of buprenorphine (8mg) or to continue buprenorphine on the day of surgery without dose reduction. The primary outcome of interest is postoperative pain scores. The secondary outcomes of interest are opioid consumption, opioid dispensing up to 30 days following the surgical procedure and OUD related symptoms, including opioid withdrawal, cravings and relapse. The investigators hypothesis is that there will be a clinically significant increase in pain scores when buprenorphine is continued in full compared to when it is continued at a lower analgesic dose. Clinical significance will be defined as a difference in composite pain scores of greater than 20% between groups. The investigators also hypothesize that opioid consumption and opioid dispensing will be greater with full dose buprenorphine continuation compared to low-dose continuation.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 18 and older
• American Society of Anesthesia health class I-III
• Currently taking buprenorphine formulation equivalent to 12mg or greater for at least 30 days for treatment of Opioid Use Disorder
• Scheduled for surgery at Maine Medical Center for a procedure with a greater than 4/10 pain intensity is expected on post-op day one.

Exclusion Criteria:

• unable to consent to the study
• currently pregnant
• current major medical illness that could limit the ability to utilize medications within our protocol driven multimodal analgesic plan (e.g. cancer, severe end-stage organ disease, or dementia)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Buprenorphine Dose Reduction; Patients instructed to reduce buprenorphine to 8mg prior to surgery	Drug: Buprenorphine; Patients randomized to this group will reduce their buprenorphine dose prior to surgery.; Drug: Buprenorphine; Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
Other: Buprenorphine Full Dose Continuation; Patients instructed to continue taking the full prescribed dose of buprenorphine.	Drug: Buprenorphine; Patients randomized to this group will reduce their buprenorphine dose prior to surgery.; Drug: Buprenorphine; Patients randomized to this group will continue their buprenorphine at the full prescribed dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Scores: 24 Hours After Surgery	Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)	24 hours after surgery
Post-operative Pain Scores: 48 Hours After Surgery	Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)	48 hours after surgery
Post-operative Pain Scores: 72 Hours After Surgery	Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)	72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	All opioids consumed through 72 hours after surgery combined into mean morphine equivalents	3 days post-op
Opioid Dispensing	Prescriptions filled for the patient in the Prescription Awareness Tool	30 days following surgery
Opioid Withdrawal	Withdrawal symptoms as measured by the Clinical Opioid Withdrawal Scale (COWS, scores can range from 0-48 [5-12 mild; 13-24, moderate; 25-36, moderately severe; >36, severe withdrawal)	1-3 hours prior to surgery
Opioid Cravings	Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings	1-3 hours prior to surgery
Opioid Cravings	Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings	30 days following surgery
Opioid Misuse	Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk)	1-3 hours prior to surgery
Opioid Misuse	Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk)	30 days following surgery
Opioid Relapse	Patient reported use of non-prescribed opioids	30 days following surgery

Collaborators and Investigators

• Sponsor: MaineHealth
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Aurora Quaye, MD, Maine Medical Center; Spectrum Healthcare Partners

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 1688818-1; U54GM115516-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No