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Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03266445
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : October 9, 2018
Information provided by (Responsible Party):
Aurora Naa-Afoley Quaye, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Pain, Acute Surgery Drug: buprenorphine/naloxone Phase 4

Detailed Description:
Opioid use disorder (OUD) is characterized by non-remitting cycles of remission and opioid abuse relapse. It is associated with a high rate of psychiatric and physical co-morbidity when left untreated. Buprenorphine and buprenorphine/naloxone are effective opioid maintenance therapy (OMT) for OUD, however, treatment of acute post-surgical pain in patients taking buprenorphine is perceived to be challenging. Although not substantiated in clinical studies, the combination of high receptor binding affinity, long half-life, and partial mu opioid receptor agonism with buprenorphine/naloxone are thought to inhibit the analgesic actions of full mu opioid receptor agonists, potentially making standard postoperative pain control strategies less effective. There is no evidence based standard of care for optimal acute pain management strategies for patients taking buprenorphine and most recommendations are based upon provider opinion- occasionally conflicting along specialty lines. Some providers, mainly consisting of surgeons and anesthesiologists, recommend that buprenorphine should be discontinued at least 72 hours prior to elective surgery and replaced with low dose opioid agonists, in the interim. Other providers, mainly comprising of psychiatrists, contend that these patients should be maintained on buprenorphine throughout the peri-operative period at either a full or reduced dose to prevent an indeterminate risk of substance abuse relapse that can occur as consequence to the abrupt termination buprenorphine in the highly stressful surgical period. This study aims to inform this important unresolved question in the clinical care of this growing population. The investigators seek to determine the effectiveness of managing postoperative pain in patients with OUD where buprenorphine/naloxone is continued perioperatively compared to patients where buprenorphine/naloxone is reduced to a lower dose. Longitudinally, the investigators also intend to determine if there is a difference in substance abuse relapse in patients where buprenorphine/naloxone is continued vs. held by using self assessments and communication with the participant's buprenorphine provider.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 8mg prior to surgery. Each group will have identical perioperative treatment plans. Primary outcome measured is pain scores following surgery.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 5, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 26, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone
Drug: buprenorphine/naloxone
The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
Other Name: Reduction vs Continuation

No Intervention: LOW-BUPRENORPHINE (control)
Participants will be randomly assigned to have their daily dose of buprenorphine/naloxone reduced to 8mg on the day of surgery

Primary Outcome Measures :
  1. Post-operative pain scores [ Time Frame: 24 hours after surgery ]
    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.

Secondary Outcome Measures :
  1. Postoperative opioid consumption [ Time Frame: 24 hours, 48 hours and 72 hours after surgery ]
    Amount of opioids needed for pain control postoperatively

  2. Post-operative pain scores [ Time Frame: 48 hours, 72 hours after surgery ]
    Level of pain on Visual Analog Scale 0-100 (0= no pain 100= worst pain imaginable) We will compare the results of the 48 and 72 hour time-points with the 24 hour time-point.

  3. Presence, severity of substance abuse [ Time Frame: 1 month after surgery ]
    Participants will complete questionnaires to identify the presence and severity of substance abuse.These values will be compared with baseline values obtained preoperatively.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03266445

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Contact: Aurora Quaye, MD 617-726-2000

Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Aurora Quaye, MD Massachusetts General Hospital
Additional Information:

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Responsible Party: Aurora Naa-Afoley Quaye, Instructor M.D., Massachusetts General Hospital Identifier: NCT03266445    
Other Study ID Numbers: 2017P001425
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aurora Naa-Afoley Quaye, Massachusetts General Hospital:
post-surgical pain
Additional relevant MeSH terms:
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Acute Pain
Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neurologic Manifestations
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists