Opioid UseNCT06358040
Opioid Dispenser for Microdiscectomy/Laminectomy
A study testing Opioid-Dispensing Device, App and Standard Opioid Pill Bottle in people with Opioid Use and Pain, Postoperative, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Pain, Postoperative, Medical Device
- What is being tested?
- Opioid-Dispensing Device, App and Standard Opioid Pill Bottle
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
William Chan, MEng, 917-260-4788, chanw@hss.edu
Alexandra Sideris, PhD, 212-774-2602, siderisa@hss.edu
About this study
Official title: Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy/Laminectomy: A Pilot Study
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
- Being tested
- Opioid-Dispensing Device, App, Standard Opioid Pill Bottle
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-Dispensing DeviceDevice
Also called Addinex
Addinex Opioid-Dispensing Device
AppOther
Also called Addinex
Addinex App
Standard Opioid Pill BottleOther
Standard Opioid Pill Bottle
| Study group | Role | What they receive |
|---|---|---|
| Standard Opioid Pill Bottle with App | Active comparator | Not described Receives: Other: App; Other: Standard Opioid Pill Bottle |
| Opioid-Dispensing Device with App | Experimental | Not described Receives: Device: Opioid-Dispensing Device; Other: App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Consumption at Postoperative Day 14 (POD14)
Cumulative Opioid Consumption at Postoperative Day 14 (POD14) following lumbar decompression (microdiscectomy/laminectomy), expressed as number of tablets and morphine equivalents (MED in mg) and collected via app starting at discharge to 14 days later.
Measured: Hospital Discharge to Postoperative Day 14
Secondary outcomes (7)
NRS pain intensity ratings
Numerical Rating Scale (NRS) Pain Intensity Ratings from 0-10, with 0 being no pain to 10 being the worst pain possible: patient-reported in app
Measured: PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
Patient satisfaction with the app and with the dispensing device
Satisfaction survey - Device group patients will rate statements on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree)
Measured: Postoperative Day 14
Frequency of reported difficulties using the device
Frequency of reported difficulties using the device assessed via initiation of patient call to study team; activation of device unlocking mechanism.
Measured: Daily up to Postoperative Day 14
Frequency of reported difficulties using the app
Frequency of reported difficulties using the app assessed via initiation of patient call/email to study team.
Measured: Daily up to Postoperative Day 14
Opioid prescription refill rates
Opioid prescription refill rates using electronic health records
Measured: 6 weeks postoperatively
Concordance of app data and medication left in the device or pill bottle (medication reconciliation)
At Postoperative Day 14, the number of pills consumed as documented via the app, compared to actual pills left over in the device/pill bottle (telemedicine medication reconciliation).
Measured: Postoperative Day 14
Generation of one-time use over-ride code
Device group: Generation of one-time use over-ride code to dispense one opioid tablet, assessed via email to study team
Measured: Daily up to Postoperative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir Kramskiy, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358040
- Sponsor's protocol ID
- 2023-0328
- Status last verified
- Nov 2025
- First submitted
- 5 Apr 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy/Laminectomy: A Pilot Study
- ClinicalTrials.gov ID
- NCT06358040
- Acronym / sponsor ID
- 2023-0328
- Conditions
- Opioid Use, Pain, Postoperative, Medical Device, Laminectomy, Diskectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Opioid Pill Bottle with App | Active comparator | Other: App, Other: Standard Opioid Pill Bottle |
| Opioid-Dispensing Device with App | Experimental | Device: Opioid-Dispensing Device, Other: App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid-Dispensing DeviceAlso: AddinexAddinex Opioid-Dispensing Device | Device | Opioid-Dispensing Device with App |
| AppAlso: AddinexAddinex App | Other | Opioid-Dispensing Device with App, Standard Opioid Pill Bottle with App |
| Standard Opioid Pill BottleStandard Opioid Pill Bottle | Other | Standard Opioid Pill Bottle with App |
Primary outcome
Cumulative Opioid Consumption at Postoperative Day 14 (POD14)
Time frame: Hospital Discharge to Postoperative Day 14
Cumulative Opioid Consumption at Postoperative Day 14 (POD14) following lumbar decompression (microdiscectomy/laminectomy), expressed as number of tablets and morphine equivalents (MED in mg) and collected via app starting at discharge to 14 days later.
7 secondary outcomes
NRS pain intensity ratings
Time frame: PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
Patient satisfaction with the app and with the dispensing device
Time frame: Postoperative Day 14
Frequency of reported difficulties using the device
Time frame: Daily up to Postoperative Day 14
Frequency of reported difficulties using the app
Time frame: Daily up to Postoperative Day 14
Opioid prescription refill rates
Time frame: 6 weeks postoperatively
Concordance of app data and medication left in the device or pill bottle (medication reconciliation)
Time frame: Postoperative Day 14
Generation of one-time use over-ride code
Time frame: Daily up to Postoperative Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vladimir Kramskiy, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid-Dispensing Device, App and Standard Opioid Pill Bottle in people with Opioid Use and Pain, Postoperative, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Chan, MEng (917-260-4788, chanw@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Opioid Consumption at Postoperative Day 14 (POD14) (time frame: Hospital Discharge to Postoperative Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.