NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

NCT07461506 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY26020068
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wisdom Teeth; Wisdom Teeth Extraction or Jaw Implant

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours

  First 48 hours post extraction

Secondary Outcomes (15)

• Opioid Consumption

  post-extraction Day 7

• Opioid Consumption

  post-extraction Day 30

• Opioid Consumption

  post-extraction Day 90

• Post-Operative Pain Score

  48 hours post-extraction

• Opioid prescription refills

  One week post extraction

Study Arms (2)

NEUROCUPLE™ Group

EXPERIMENTAL

This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-days following their Wisdom Teeth Extraction procedure

Device: NEUROCUPLE™ Patch

Sham Group

SHAM COMPARATOR

This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-days following their Wisdom Tooth Extraction procedure

Device: Sham Patch

Interventions

NEUROCUPLE™ Patch DEVICE

nCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain.

NEUROCUPLE™ Group

Sham Patch DEVICE

The sham patch is identical to the active patch but with no active agents.

Sham Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• nCap Medical: lead
• University of Pittsburgh: collaborator

Study Sites (1)

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, 15261, United States

Location

Study Officials

• Daniel Hawkins, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy L Monroe

CONTACT

4126236382; clingrantinfo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Enrolled subjects will be randomized to receive either NeuroCuple or placebo (sham device). Each randomized participant will be assigned a subject ID number, and this ID number will correspond to a treatment allocation number based on a pre-designed randomization schema. On Day 1 (day of surgery), participants will receive two NeuroCuple strips (2" x 3" average cheek size) or two shams applied by a trained researcher at their first study visit and participants and their caregivers (if requested) will be shown how to apply, remove, and care for the strip. The strips will be contained within a sleeve that can be wrapped around the jaw and top of head. Participants will be instructed to wear the intervention for \>12-18 hours per day for 2 days only since the most intense pain following wisdom tooth extraction is usually experienced in the first 48 hours.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)