The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

NCT04981678 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 1688818-1U54GM115516-06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Opioid Consumption

  3 days post-op

• Opioid Dispensing

  30 days following surgery

• Opioid Withdrawal

  1-3 hours prior to surgery

• Opioid Cravings

  1-3 hours prior to surgery

• Opioid Cravings

  30 days following surgery

Study Arms (2)

Buprenorphine Dose Reduction

OTHER

Patients instructed to reduce buprenorphine to 8mg prior to surgery

Drug: Buprenorphine

Buprenorphine Full Dose Continuation

OTHER

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

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

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

Buprenorphine Dose Reduction

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• MaineHealth: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Early termination due to low enrollment; limited data analysis performed because of the small number of subjects.

Results Point of Contact

• Title: Lead Research Coordinator
• Organization: MaineHealth, Department of Anethesiology

janelle.richard@mainehealth.org

207-662-2862

Study Officials

• Aurora Quaye, MD

  Maine Medical Center; Spectrum Healthcare Partners

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 29, 2021
• Study Start: January 1, 2022
• Primary Completion: September 15, 2023
• Study Completion: October 16, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)