Recruiting

Opioid Dispenser

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT06358040

Conditions

Opioid Use

Pain, Postoperative

Medical Device

Laminectomy

Diskectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Opioid-Dispensing Device

App

Standard Opioid Pill Bottle

Study Details

Brief summary:

The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers.

Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles.

Conditions

Opioid Use

Pain, Postoperative

Medical Device

Laminectomy

Diskectomy

Study ID

NCT06358040

Start date

Oct, 2026

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • opioid-naive patients or intermittent opioid users within 3 months of scheduled surgery
  • At least 18 years old
  • presenting for primary elective one-level lumbar laminectomy and/or discectomy via posterior approach with participating surgeon
  • planned discharge on day of surgery/23 hour admission
  • planned discharge to home

Exclusion Criteria:

  • patients with opioid-tolerance
  • patients without a smart-phone or without the ability to perform Telehealth visits
  • patients unable to utilize the medication dispensing device
  • patients presenting for other surgeries/surgeries with combined anterior/lateral approaches
  • patient refusal
  • allergy or intolerance to opioids
  • planned admission after surgery
  • planned discharge disposition to nursing facility or skilled rehabilitation
  • planned use of or preference for opioid other than oxycodone
  • patients who are pregnant

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard Opioid Pill Bottle with App

experimental: Opioid-Dispensing Device with App

Interventions

Opioid-Dispensing Device

Addinex Opioid-Dispensing Device

App

Addinex App

Standard Opioid Pill Bottle

Standard Opioid Pill Bottle

Primary outcome measure

  • Cumulative Opioid Consumption at Postoperative Day 14 (POD14) [ Time Frame: Hospital Discharge to Postoperative Day 14 ]

Central Contacts and Locations

Central contacts

William Chan, MEng

917-260-4788chanw@hss.edu

Alexandra Sideris, PhD

212-774-2602siderisa@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

William Chan, MEng

917-260-4788chanw@hss.edu

Alexandra Sideris, PhD

212-774-2602siderisa@hss.edu

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Dec 8, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2025-12-08.