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NCT04091009
Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain and Opioid Use Disorder Symptoms
Phase 4 trial testing Buprenorphine/naloxone in Opioid-use Disorder. Withdrawn.
1 December 2025
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 October 2019 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
Drugs / interventions tested
- Buprenorphine/naloxone
Conditions studied
- Opioid-use Disorder — all drugs for Opioid-use Disorder →
- Opioid Use Disorder, Mild — all drugs for Opioid Use Disorder, Mild →
Sponsor
Massachusetts General Hospital
Who can join
Adults 18 to 65, any sex, with Opioid-use Disorder or Opioid Use Disorder, Mild. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pain scores at 24 hours post-operative procedure
Time frame: 24 hours
Average pain scores at 24 hours post-op
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04091009
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Opioid-use Disorder
Currently open trials in the same condition.
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Other Massachusetts General Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04091009 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 24 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04091009.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing