drugset / Trial / NCT04091009

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

NCT04091009 ↗

Phase 4 Withdrawn Massachusetts General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain. The investigators want to compare how well pain is managed after surgery ("post-op") in two groups: The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery. The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, participants will be put back on their full dose of buprenorphine. The investigators also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.

Timeline

Start
2019-10
Primary completion
2025-12
Completion
2025-12

Outcome

Outcome not reported

Stopped (Business): “lack of funding”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buprenorphine/naloxone Unknown 8 mg —

Indications