Mobile Health (mHealth) App for Safe Opioid Use

NCT04462250 | Withdrawn

• 1 other identifier: Pro2020001699
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A key driver of the current opioid overdose epidemic is the misuse of legitimately prescribed opioid medications. Patient education through use of mobile technology may help to increase knowledge of appropriate use of opioid medications; however, knowledge does not always translate into behavior modification. Therefore, there is a need for more research into patient-facing technology that can increase both knowledge and behaviors consistent with appropriate opioid use. These needs have been amplified by the severe acute respiratory syndrome coronavirus-2 (COVID-19) pandemic, which has exposed healthcare disparities, heightened the risk for mental and behavioral health disorders, and dramatically increased reliance on telehealth technologies. It is critically important that telehealth solutions be accessible and user-friendly for all consumers, particularly members of underserved communities with limited digital health literacy. This feasibility study will develop a mobile health app to improve appropriate use of opioid medications among patients with a prescription to treat non-cancer pain. The study will use focus groups with consumers and providers to determine the content and features to be included in the app and will test the feasibility of implementing a contingency management approach (i.e., rewards system) with the app using a randomized control trial. The key outcome of interest is confirmation of the design and operating specifications of the app, including the use of contingency management. Secondary outcomes of interest are the overall rating of the app and an increase in knowledge among users regarding the safe use, storage, and disposal of opioid medications.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Device functionality

  Confirmation that the app features work as intended based on user input

  Assessed at the end of the one-week trial

Secondary Outcomes (2)

• Mobile App Rating Scale (MARS)

  Data collected through app and telephone interviews at the end of the one-week trial

• Change in knowledge quiz score

  Change in score as assessed at the end of the one-week trial

Study Arms (3)

Control

ACTIVE COMPARATOR

Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided.

Device: Prescription Opioid Management App

Contingency Management - Virtual Pet

ACTIVE COMPARATOR

Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which can be used in the care of a virtual pet.

Device: Prescription Opioid Management App

Contingency Management - Monetary

ACTIVE COMPARATOR

Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which will be paid out at the end of the one-week trial in the form of a monetary reward.

Device: Prescription Opioid Management App

Interventions

Prescription Opioid Management App DEVICE

Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal

Contingency Management - Monetary; Contingency Management - Virtual Pet; Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has current prescription for opioid medication
• Any ethnic group
• Served through the following programs of partnering organization: primary medical care, transgender medical care, HIV and sexually transmitted infection (STI) screening and counseling, LGBTQ services, pre-exposure prophylaxis and post exposure prophylaxis services, health education, clinical research, case management, psychosocial services, nutrition counseling, treatment adherence
• Owns an Android-base smartphone

You may not qualify if:

• Unable to provide informed consent
• Pregnant women
• Currently being treated for/history of mental health or substance use disorder

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

North Jersey Community Research Initiative

Newark, New Jersey, 07103, United States

Location

Study Officials

• Ann D Bagchi, PhD,DNP

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will enter all data using a numeric identifier assigned by a third-party recruiter
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 8, 2020
• Study Start: August 24, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)