Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post Operative Opioid Use Disorder Symptoms
1 other identifier
interventional
76
0 countries
N/A
Brief Summary
The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in patients with history of Opioid Use Disorder (OUD) scheduled for surgery compared to reduced dose buprenorphine/naloxone prior to surgery on pain scores, opioid consumption, depressive symptoms and severity of substance use dependence- including record of problematic use of any non-prescribed opioids, alcohol and illicit narcotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2018
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2022
CompletedOctober 9, 2018
October 1, 2018
3.2 years
August 28, 2017
October 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative pain scores
Level of pain on a Visual Analog Scale of 0-100 (0=no pain; 100=worst pain imaginable) This scale will be used to quantify the varying degrees of pain or discomfort experienced by the participant.
24 hours after surgery
Secondary Outcomes (3)
Postoperative opioid consumption
24 hours, 48 hours and 72 hours after surgery
Post-operative pain scores
48 hours, 72 hours after surgery
Presence, severity of substance abuse
1 month after surgery
Study Arms (2)
FULL-BUPRENORPHINE
ACTIVE COMPARATORParticipants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone
LOW-BUPRENORPHINE (control)
NO INTERVENTIONParticipants will be randomly assigned to have their daily dose of buprenorphine/naloxone reduced to 8mg on the day of surgery
Interventions
The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
Eligibility Criteria
You may qualify if:
- currently taking buprenorphine or buprenorphine/naloxone daily for treatment of opioid use disorder by DSM-V criteria
- on buprenorphine or buprenorphine/naloxone dose of greater than 8mg for at least 30 days
- ASA health class I-III
You may not qualify if:
- Unable to consent to the study
- Significant pulmonary or cardiac disease
- Renal insufficiency with a glomerular filtration rate less than 30ml/min
- Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score of greater than 25
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (13)
McLellan AT, Lewis DC, O'Brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000 Oct 4;284(13):1689-95. doi: 10.1001/jama.284.13.1689.
PMID: 11015800BACKGROUNDScott CK, Dennis ML, Laudet A, Funk RR, Simeone RS. Surviving drug addiction: the effect of treatment and abstinence on mortality. Am J Public Health. 2011 Apr;101(4):737-44. doi: 10.2105/AJPH.2010.197038. Epub 2011 Feb 17.
PMID: 21330586BACKGROUNDDegenhardt L, Bucello C, Mathers B, Briegleb C, Ali H, Hickman M, McLaren J. Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction. 2011 Jan;106(1):32-51. doi: 10.1111/j.1360-0443.2010.03140.x. Epub 2010 Nov 4.
PMID: 21054613BACKGROUNDSchuckit MA. Treatment of Opioid-Use Disorders. N Engl J Med. 2016 Jul 28;375(4):357-68. doi: 10.1056/NEJMra1604339. No abstract available.
PMID: 27464203BACKGROUNDGordon AJ, Lo-Ciganic WH, Cochran G, Gellad WF, Cathers T, Kelley D, Donohue JM. Patterns and Quality of Buprenorphine Opioid Agonist Treatment in a Large Medicaid Program. J Addict Med. 2015 Nov-Dec;9(6):470-7. doi: 10.1097/ADM.0000000000000164.
PMID: 26517324BACKGROUNDRoberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. doi: 10.1177/0310057X0503300104.
PMID: 15957687BACKGROUNDBryson EO. The perioperative management of patients maintained on medications used to manage opioid addiction. Curr Opin Anaesthesiol. 2014 Jun;27(3):359-64. doi: 10.1097/ACO.0000000000000052.
PMID: 24500338BACKGROUNDMcCormick Z, Chu SK, Chang-Chien GC, Joseph P. Acute pain control challenges with buprenorphine/naloxone therapy in a patient with compartment syndrome secondary to McArdle's disease: a case report and review. Pain Med. 2013 Aug;14(8):1187-91. doi: 10.1111/pme.12135. Epub 2013 May 3.
PMID: 23647815BACKGROUNDHuang A, Katznelson R, de Perrot M, Clarke H. Perioperative management of a patient undergoing Clagett window closure stabilized on Suboxone(R) for chronic pain: a case report. Can J Anaesth. 2014 Sep;61(9):826-31. doi: 10.1007/s12630-014-0193-y. Epub 2014 Jul 2.
PMID: 24985936BACKGROUNDKornfeld H, Manfredi L. Effectiveness of full agonist opioids in patients stabilized on buprenorphine undergoing major surgery: a case series. Am J Ther. 2010 Sep-Oct;17(5):523-8. doi: 10.1097/MJT.0b013e3181be0804.
PMID: 19918165BACKGROUNDMacintyre PE, Russell RA, Usher KA, Gaughwin M, Huxtable CA. Pain relief and opioid requirements in the first 24 hours after surgery in patients taking buprenorphine and methadone opioid substitution therapy. Anaesth Intensive Care. 2013 Mar;41(2):222-30. doi: 10.1177/0310057X1304100212.
PMID: 23530789BACKGROUNDKelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.
PMID: 11354213BACKGROUNDWilkinson KM, Krige A, Brearley SG, Lane S, Scott M, Gordon AC, Carlson GL. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial. Trials. 2014 Oct 21;15:400. doi: 10.1186/1745-6215-15-400.
PMID: 25336055BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aurora Quaye, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor M.D.
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
October 5, 2018
Primary Completion
December 31, 2021
Study Completion
February 26, 2022
Last Updated
October 9, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share
IPD will only be available to researchers involved in the study. All data will be collected and stored securely using the Redcap system to preserve privacy and confidentiality. Information regarding substance abuse history, including illicit narcotic use, will remain confidential and personal identifiers will be removed during data storage. Only members of the research team will have access to the data that participants have consented to provide. Participants will be informed that they have the right to not answer any question that makes them feel uncomfortable.