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NCT04981678 · ClinicalTrials.gov registry record · Phase 4
The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
A Phase 4 study, sponsored by MaineHealth.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT04981678: Clinical Trial Phase 4 study, sponsored by MaineHealth.
NCT04981678 is a Phase 4 study that was terminated before completion, run by MaineHealth. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04981678, a Phase 4 study, was terminated before completion, sponsored by MaineHealth.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance Abuse and Mental Health Services Administration (SAMHSA). There is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. Preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (OUD) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. Since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.
Primary Outcome
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 4 |
Why NCT04981678 stopped before completion
NCT04981678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine is the first listed.
NCT04981678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04981678 about?
NCT04981678 is a clinical study titled "The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder". There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strateg...
What is the current status of trial NCT04981678?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2022-01-01. Estimated completion is 2023-10-16.
What interventions are being tested in trial NCT04981678?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT04981678?
This trial is sponsored by MaineHealth, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04981678's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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