Clinical trial NCT04981678: The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
Official title: A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Opioid-use Disorder
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-07-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Post-operative Pain Scores: 24 Hours After Surgery
timeFrame: 24 hours after surgery
measure: Post-operative Pain Scores: 48 Hours After Surgery
timeFrame: 48 hours after surgery
measure: Post-operative Pain Scores: 72 Hours After Surgery
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 3 days post-op
measure: Opioid Dispensing
timeFrame: 30 days following surgery
measure: Opioid Withdrawal
timeFrame: 1-3 hours prior to surgery
measure: Opioid Cravings
timeFrame: 1-3 hours prior to surgery
measure: Opioid Cravings
timeFrame: 30 days following surgery
measure: Opioid Misuse
timeFrame: 1-3 hours prior to surgery
measure: Opioid Misuse
timeFrame: 30 days following surgery
measure: Opioid Relapse
timeFrame: 30 days following surgery
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: Maine Medical Center; Spectrum Healthcare Partners
name: Aurora Quaye, MD
role: PRINCIPAL_INVESTIGATOR
References: