The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04981678
• Other study ID #: 1688818-1
• Status: Terminated
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: October 16, 2023

Study information

• Verified date: December 2023
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 16, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Drug:
• Buprenorphine
Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
• Buprenorphine
Patients randomized to this group will continue their buprenorphine at the full prescribed dose.

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Aurora Quaye	MaineHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Opioid consumption	All opioids consumed through 72 hours after surgery combined into mean morphine equivalents	3 days post-op
Secondary	Opioid dispensing	All prescriptions filled for the patient in the Prescription Awareness Tool	30 days following surgery
Secondary	Opioid Withdrawal	Measured by the Clinical Opioid Withdrawal Scale scores can range from 0-48 (5-12 mild; 13-24 moderate; 25-36 moderately severe; more than 36 severe withdrawal)	30 days following surgery
Secondary	Opioid Cravings	Measured by the Opioid Craving Scale (scale ranges from 0-30 with higher scores indicating higher levels of cravings)	30 days following surgery
Secondary	Opioid Misuse	Measured by the Current Opioid Misuse Measure (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). and a 30-day Timeline Followback that will ask patients to report instances of opioid use for the 30 days after surgery	30 days following surgery
Secondary	Opioid Relapse	Measured by a 30-day Timeline Followback that will ask patients to report instances of opioid use for the 30 days after surgery.	30 days following surgery