Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
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ClinicalTrials.gov Identifier: NCT03266445 |
Recruitment Status :
Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : October 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Opioid-use Disorder Pain, Acute Surgery | Drug: buprenorphine/naloxone | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: FULL-BUPRENORPHINE
Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone
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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
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- 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.
- Postoperative opioid consumption [ Time Frame: 24 hours, 48 hours and 72 hours after surgery ]Amount of opioids needed for pain control postoperatively
- 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.
- 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.

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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

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 ClinicalTrials.gov identifier (NCT number): NCT03266445
Contact: Aurora Quaye, MD | 617-726-2000 | aquaye@partners.org |
Principal Investigator: | Aurora Quaye, MD | Massachusetts General Hospital |
Publications:
Responsible Party: | Aurora Naa-Afoley Quaye, Instructor M.D., Massachusetts General Hospital |
ClinicalTrials.gov 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. |
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 |
relapse buprenorphine/naloxone opioids narcotics post-surgical pain |
Acute Pain Pain Neurologic Manifestations Buprenorphine Buprenorphine, Naloxone Drug Combination Naloxone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |