NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

Официальное название

Mitigating Opioid Use Disorder Risk With Enhanced Opioid Sparing Pain Relief for Wisdom Teeth Extractions With a Novel Nanotechnology

Обзор

This is a randomized (1:1), placebo-controlled clinical trial that will examine the feasibility and effectiveness of a 2-day application of the NeuroCuple device for pain relief and reduction of opioid use following wisdom teeth extraction. The primary objectives are to determine whether the active NeuroCuple reduces postoperative pain and decreases opioid consumption compared to a sham (placebo) device. A total of 120 participants will be enrolled over a 1-year period and randomized to receive either the active device or an identical-appearing placebo device without the captor array layer.

Подробное описание

This will be a triple-blind randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 2-days only 12-18h/day, mostly at night application of the NeuroCuple for reducing surgical pain and opioid use after third molar extraction. Study subjects, 18-40y, will be followed on days 1, 7, 1 month, and 3 months post-extraction via REDCap surveys with text, email, or phone reminders. Results will establish NeuroCuple as an effective non-opioid pain management approach for post-dental extraction pain. Importantly, a sham device that looks exactly like the active device will be implemented, allowing for a robust triple-blinded RCT. A prototype specific for this STTR's dental extraction indication has been designed, with the device inside a sleeve over the cheek that wraps around the head with feedback from dentists and patients for easier and better use compliance, efficacy, FDA indication and reimbursement

Вмешательства

• Устройство NEUROCUPLE™ Patch
  nCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain.
• Устройство Sham Patch
  The sham patch is identical to the active patch but with no active agents.

Первичные конечные точки

• Opioid Consumption [Срок оценки: First 48 hours post extraction]

Вторичные конечные точки (12)

• Opioid Consumption [Срок оценки: post-extraction Day 7]
• Opioid Consumption [Срок оценки: post-extraction Day 30]
• Opioid Consumption [Срок оценки: post-extraction Day 90]
• Post-Operative Pain Score [Срок оценки: 48 hours post-extraction]
• Opioid prescription refills [Срок оценки: One week post extraction]
• Opioid prescription refills [Срок оценки: post-extraction day 30]
• Opioid prescription refills [Срок оценки: post-extraction day 90]
• Pain Interference [Срок оценки: post-extraction days 1-7, 30 days and 90 days]
• Daily use of non-opioid analgesics [Срок оценки: post-extraction days 1-7]
• Time to normalcy (work or activity, and solid food intake) [Срок оценки: post-extraction days 1-7]
• Adverse events (i.e., ER visit, hospitalization, opioid side-effects, intervention side effects) [Срок оценки: post-extraction days 1-7]
• Sleep quality [Срок оценки: post-extraction days 1-7]

Критерии участия

Критерии включения

• Males and females of all races and ethnicity
• >18 to 50 years
• Healthy based on medical history
• Scheduled for elective extraction of one or more partially or fully impacted mandibular third molars
• Able to understand and sign the informed consent form
• Willing and able to comply with all study procedures
• Available for the duration of the study
• Able to understand the directions for data gathering instruments

Критерии исключения

• Children (< 18 years of age)
• T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
• Other concomitant surgery being performed in addition to third molar extraction
• History of gastrointestinal bleeding and/or peptic ulcer, renal disease (excluding kidney stones), hepatic disease, bleeding disorder, respiratory depression
• History of respiratory depression with opioids or other anesthetic drugs that required postoperative ventilatory support or naloxone
• Active or untreated asthma
• Known allergy to ibuprofen, acetaminophen, oxycodone, hydrocodone, and/or anesthesia
• Currently taking CYP3A4 inhibitors, azole-antifungal agents, protease inhibitors, or CNS depressants
• Consumes three or more alcoholic drinks per day
• Active alcoholism or illicit drug abuse (defined as daily use of illicit drugs)
• History of substance or alcohol abuse
• History of substance or alcohol abuse in a first-degree relative
• No more than one opioid prescription filled within the past 12 months (self-report and PDMP)
• Pregnant or lactating women

Sex, race, and ethnicity will not be used as exclusion criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh School of Dental Medicine — Pittsburgh

Идентификаторы

NCT: NCT07461506 · STUDY26020068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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