- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04981678
The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
December 14, 2023 updated by: Aurora Quaye
A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Janelle Richard
- Phone Number: 2076622862
- Email: richaj3@mmc.org
Study Locations
-
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Buprenorphine Dose Reduction
Patients instructed to reduce buprenorphine to 8mg prior to surgery
|
Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
Other: Buprenorphine Full Dose Continuation
Patients instructed to continue taking the full prescribed dose of buprenorphine.
|
Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain scores: 24 hours after surgery
Time Frame: 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)
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24 hours after surgery
|
Post-operative pain scores: 48 hours after surgery
Time Frame: 48 hours after surgery
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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
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid consumption
Time Frame: 3 days post-op
|
All opioids consumed through 72 hours after surgery combined into mean morphine equivalents
|
3 days post-op
|
Opioid dispensing
Time Frame: 30 days following surgery
|
All prescriptions filled for the patient in the Prescription Awareness Tool
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30 days following surgery
|
Opioid Withdrawal
Time Frame: 30 days following surgery
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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)
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30 days following surgery
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Opioid Cravings
Time Frame: 30 days following surgery
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Measured by the Opioid Craving Scale (scale ranges from 0-30 with higher scores indicating higher levels of cravings)
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30 days following surgery
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Opioid Misuse
Time Frame: 30 days following surgery
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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
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30 days following surgery
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Opioid Relapse
Time Frame: 30 days following surgery
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Measured by a 30-day Timeline Followback that will ask patients to report instances of opioid use for the 30 days after surgery.
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30 days following surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aurora Quaye, MD, Maine Medical Center; Spectrum Healthcare Partners
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
September 15, 2023
Study Completion (Actual)
October 16, 2023
Study Registration Dates
First Submitted
July 8, 2021
First Submitted That Met QC Criteria
July 28, 2021
First Posted (Actual)
July 29, 2021
Study Record Updates
Last Update Posted (Actual)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
Other Study ID Numbers
- 1688818-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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