Opioid Dispensing Device for Post-Operative Pain in Cancer Patients

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05585788
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Addinex Device (ADX-27) — DEVICE
    The device operates without the use of any electronics, wireless or firmware requirements. This is achieved through its mechanical system which uses a different randomized "passcode" for each dose that is loaded into a circular drum inside the device. The "passcodes" are provided by an online server through either a mobile app, web app, text service or call in service. The online server provides "passcodes" on a request basis, while following instructions set by the treating physicians.

Study Details

This research study will evaluate the use of, and participants experience with, a new device called Addinex that safely stores and dispenses opioid medication. The purpose of this study is to evaluate the use of the Addinex device in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery. Participants will be asked to answer questions about their medical history and background, fill out questionnaires, use a mobile application associated with the device, and undergo a phone interview one month after stopping use of the device. This study aims to find out how participants like using the Addinex device as opposed to a traditional pill bottle. Results of this study will help determine if the Addinex device could be useful to patients in the future after surgeries, as opposed to typical pill bottles.

Key Dates

Start date
Oct 5, 2020
Status verified
May 2025
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Other: Addinex system
    The Addinex system is designed to dispense opioid medication to patients on a provider-determined schedule, to track patient use of the device, and to allow for return and disposal of unused opioids. This study will determine the feasibility of using Addinex for these purposes.

Primary Outcome Measure

Rate of Device Return [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Dawn Hershman, MD
[email protected]
212-305-1945

Find similar trials in New York, NY

By condition
Breast cancerSubstance use disorder
By specialty
OncologyBreast oncologyWomen's healthBehavioral healthAddiction medicine
By research site
Columbia University Medical Center· New York, NY

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