Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2026-10-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
NCT05058287
Continuous Erector Spinae Block for Analgesia Following Lumbar Decompression
NCT06987409
Study of Opioid Use After Lumbar and Cervical Spine Surgery
NCT02674711
IONSYS Feasibility Study
NCT03021083
Prospective Study of Minimally Invasive Spine Surgery
NCT01045473
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Opioid Pill Bottle with App
App
Addinex App
Standard Opioid Pill Bottle
Standard Opioid Pill Bottle
Opioid-Dispensing Device with App
Opioid-Dispensing Device
Addinex Opioid-Dispensing Device
App
Addinex App
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Opioid-Dispensing Device
Addinex Opioid-Dispensing Device
App
Addinex App
Standard Opioid Pill Bottle
Standard Opioid Pill Bottle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital for Special Surgery, New York
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vladimir Kramskiy, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital for Special Surgery
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-0328
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.