The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

NCT ID: NCT04981678

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-10-16

Brief Summary

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.

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Buprenorphine Dose Reduction

Patients instructed to reduce buprenorphine to 8mg prior to surgery

Group Type: OTHER

Buprenorphine

Intervention Type: DRUG

Patients randomized to this group will reduce their buprenorphine dose prior to surgery.

Buprenorphine Full Dose Continuation

Patients instructed to continue taking the full prescribed dose of buprenorphine.

Group Type: OTHER

Buprenorphine

Intervention Type: DRUG

Patients randomized to this group will continue their buprenorphine at the full prescribed dose.

Interventions

Buprenorphine

Patients randomized to this group will reduce their buprenorphine dose prior to surgery.

Intervention Type: DRUG

Buprenorphine

Patients randomized to this group will continue their buprenorphine at the full prescribed dose.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

MaineHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurora Quaye, MD

Role: PRINCIPAL_INVESTIGATOR

Maine Medical Center; Spectrum Healthcare Partners

Locations

Maine Medical Center

Portland, Maine, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U54GM115516-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1688818-1

Identifier Type: -

Identifier Source: org_study_id