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The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

NCT04981678 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-13

Study results available
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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.

Conditions

  • Opioid-use Disorder

Interventions

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.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • MaineHealth

    lead OTHER

Principal Investigators

  • Aurora Quaye, MD · Maine Medical Center; Spectrum Healthcare Partners

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-09-15
Completion
2023-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04981678 on ClinicalTrials.gov