Opioid UseNCT04462250
Mobile Health (mHealth) App for Safe Opioid Use
A study testing Prescription Opioid Management App in people with Opioid Use, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Prescription Opioid Management App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- Pregnant women
- Currently being treated for/history of mental health or substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
North Jersey Community Research Initiative
Newark, New Jersey, 07103
About this study
Official title: Development of a Mobile Health App to Improve the Safe Use, Storage, and Disposal of Opioid Medications
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
- Being tested
- Prescription Opioid Management App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription Opioid Management AppDevice
Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Prescription Opioid Management App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device functionality
Confirmation that the app features work as intended based on user input
Measured: Assessed at the end of the one-week trial
Secondary outcomes (2)
Mobile App Rating Scale (MARS)
Participants' assessment of functionality and utility of app with 19 items scored from 1 to 5 (overall score range 19 to 95) where higher scores indicate better app rating
Measured: Data collected through app and telephone interviews at the end of the one-week trial
Change in knowledge quiz score
Participants will show an increase in knowledge related to the safe used, storage, and disposal of opioid medications based on a 10-item, investigator created, pre/post quiz (total score range of 1 to 10) designed to address key educational components of the app
Measured: Change in score as assessed at the end of the one-week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start24 Aug 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Due to COVID the study couldn't be completed. Funds were returned to the funding agency.
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.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann D. Bagchi, PhD, DNP, Rutgers, The State University of New Jersey
- Investigators
- Ann D Bagchi, PhD,DNP, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462250
- Sponsor's protocol ID
- Pro2020001699
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2020
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mobile Health App to Improve the Safe Use, Storage, and Disposal of Opioid Medications
- ClinicalTrials.gov ID
- NCT04462250
- Acronym / sponsor ID
- Pro2020001699
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID the study couldn't be completed. Funds were returned to the funding agency.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 8 Jul 2020 (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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Prescription Opioid Management AppSubjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided. |
| Contingency Management - Virtual Pet | Active comparator | Device: Prescription Opioid Management AppSubjects 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. |
| Contingency Management - Monetary | Active comparator | Device: Prescription Opioid Management AppSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Pregnant women
- Currently being treated for/history of mental health or substance use disorder
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 |
|---|---|---|
| Prescription Opioid Management AppSmartphone application that provides education and reinforcement of safe opioid use, storage, and disposal | Device | Contingency Management - Monetary, Contingency Management - Virtual Pet, Control |
Primary outcome
Device functionality
Time frame: Assessed at the end of the one-week trial
Confirmation that the app features work as intended based on user input
2 secondary outcomes
Mobile App Rating Scale (MARS)
Time frame: Data collected through app and telephone interviews at the end of the one-week trial
Change in knowledge quiz score
Time frame: Change in score as assessed at the end of the one-week trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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. This study is not recruiting at the moment.
Ann D Bagchi, PhD,DNP principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription Opioid Management App in people with Opioid Use, run by Rutgers, The State University of New Jersey 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 16 Apr 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device functionality (time frame: Assessed at the end of the one-week trial). 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 16 Apr 2026.