Smartphone App for Opioid Use Disorder

Overseen By Rosemarie Davidson, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western Michigan University

Must be taking: Medication assisted treatment

Disqualifiers: Alcohol use disorder, Incarceration, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

250 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have started or be willing to start medication-assisted treatment for opioid use disorder.

What data supports the effectiveness of the treatment Smartphone App for Opioid Use Disorder?

Research shows that mobile apps can help people understand and use medication-assisted treatment (MAT) for opioid use disorder more effectively. Apps like MySafeRx and uMAT-R have been found to be useful and acceptable for people in treatment, providing support and information that can improve treatment outcomes. ^{1 2 3 4 5}

Is the smartphone app for opioid use disorder safe for humans?

A study evaluated the safety of a digital therapeutic used alongside buprenorphine for treating opioid use disorder, suggesting it is generally safe for humans. ^{1 3 5 6 7}

How is the Smartphone App for Opioid Use Disorder treatment different from other treatments?

The Smartphone App for Opioid Use Disorder is unique because it provides a digital, low-cost, and accessible way to support recovery by offering scientifically-backed health information and addressing common misconceptions about medication-assisted treatment (MAT), which can be barriers to treatment entry. ^{1 5 6 8 9}

What is the purpose of this trial?

The purpose of the research is to check whether services and materials made available through a smartphone app are helpful to people who have been diagnosed with opioid use disorder (OUD). Participants are asked to use an app to submit videos of themselves taking salivary drug tests to a secure online system. The app includes reminders, rewards, and activities, as well as access to live support. Study participation lasts one year and includes about 30 minutes each week submitting videos, an hour-long interview to get started, and hour-long interviews once every three months after that over the course of the year.

Eligibility Criteria

This trial is for adults over 18 in the U.S. who have opioid use disorder, can read and speak English, own a compatible smartphone, and have used opioids recently. They should be starting or already receiving medication-assisted treatment and have an ASAM CO-Triage score from L1 to L3.1.

Inclusion Criteria

I am willing to start or have started medication-assisted treatment in the last 45 days.

Must have an ASAM CO-Triage score between L1 and L3.1

Reads and speaks English fluently

Exclusion Criteria

Is currently enrolled in another study involving substance abuse treatment

Has concurrent alcohol use disorder

Is currently incarcerated

Timeline

Welcome Period

Participants complete the Welcome Period to learn the basics of the DynamiCare app and perform practice saliva tests.

2-4 weeks

1 orientation session (virtual)

Study Period

Participants use the smartphone app for self-monitoring and receive incentives for drug abstinence and treatment attendance.

48 weeks

Weekly video submissions, quarterly interviews (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the main study period.

4 weeks

Treatment Details

Interventions

• OUD Smartphone Services

Trial Overview The study tests if a smartphone app providing reminders, rewards, cognitive-behavior therapy modules, wellness activities, and live support helps people with opioid addiction. Participants submit weekly drug test videos for one year.

Participant Groups

Group I: Abstinence reinforcement Experimental Treatment 3 Interventions

Participants earn incentives for submission of salivary drug toxicology video selfies that show test results consistent with the goals of treatment. Goals are abstinence-based (i.e., relate to which tested substances should be negative on the test given the medications that the particular participant has been prescribed). Incentives are also provided for attendance at treatment-related appointments and for completion of self-paced cognitive behavior therapy modules available via the smartphone app.

Group II: Sample-contingent control Placebo Group 3 Interventions

Identical to the experimental group except that incentives are available only for submission of selfie-videos that show test results, without regard to the results of the salivary drug toxicology test. Similarly, incentives are not provided for appointments or completion of wellness modules.

OUD Smartphone Services is already approved in United States for the following indications:

Approved in United States as OUD Smartphone Services for:

• Opioid Use Disorder

Who Is Running the Clinical Trial?

Western Michigan University

Lead Sponsor

Trials

18

Recruited

2,900+

RTI International

Collaborator

Trials

201

Recruited

942,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

DynamiCare Health Inc.

Collaborator

Trials

1

Recruited

250+

Findings from Research

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

Health information technologies, like mobile phone applications and electronic health records, can improve treatment outcomes for people with substance use disorders by making evidence-based therapies more accessible and easier to implement.

A clinical case demonstrated that using text messaging for communication between a buprenorphine provider and a patient allowed for effective home induction onto buprenorphine, showing a practical application of technology in managing opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. Tofighi, B., Grossman, E., Sherman, S., et al.[2018]

A significant increase in Opioid Use Disorder (OUD) diagnoses during pregnancy highlights the need for effective treatment solutions, which this study addresses through feedback from 18 peripartum individuals and 19 obstetric providers.

The development of the Listening to Women and Pregnant and Postpartum People (LTWP) program, informed by qualitative interviews, aims to enhance the implementation of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) in prenatal care, although initial feedback indicated a lack of enthusiasm for the web-based intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. Guille, C., Hall, C., King, C., et al.[2023]

A study analyzing over 2.3 million treatment episodes for opioid use disorder (OUD) identified key risk factors for premature exit from treatment, with service setting, geographic region, and payment source being the most influential.

The analysis revealed that factors like employment status and wait time to enter treatment significantly impacted retention, especially in shorter treatment durations, highlighting the need for targeted interventions to improve treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying key risk factors for premature discontinuation of opioid use disorder treatment in the United States: A predictive modeling study. Stafford, C., Marrero, WJ., Naumann, RB., et al.[2022]

Patients with opioid use disorder (OUD) who engaged with the prescription digital therapeutic reSET-O® experienced a significant cost reduction of $2708 per patient over 9 months compared to those who did not engage with the therapy, despite similar adherence to buprenorphine treatment.

The study involved a retrospective analysis of 444 patients who engaged with reSET-O and 64 non-engaged patients, showing that engaging with the digital therapeutic led to lower healthcare resource utilization and costs for both inpatient and outpatient services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. Velez, FF., Colman, S., Kauffman, L., et al.[2022]

The HOPE mobile app was developed based on feedback from 16 interviews with patients and providers, incorporating features for mood tracking, treatment adherence, and community support, which were well-received by users.

In a 6-month pilot study with 25 patients, the app demonstrated high usability scores (mean 86.9 for patients and 83.3 for providers), indicating that it effectively supports individuals undergoing medication-assisted treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. Waselewski, ME., Flickinger, TE., Canan, C., et al.[2021]

Patients using a fully virtual telemedicine service for opioid use disorder (tele-OUD) reported significant advantages, including a more patient-centered approach and reduced social barriers to treatment, based on interviews with 20 adults who had received 3 to 5 weeks of care.

Nearly all participants appreciated the quick initiation of medication for opioid use disorder (MOUD) through tele-OUD, indicating its potential effectiveness in improving access to treatment, although further research is needed to assess long-term outcomes and suitability for different recovery stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of Patients Receiving Telemedicine Services for Opioid Use Disorder Treatment: A Qualitative Analysis of User Experiences. Sousa, JL., Raja, P., Huskamp, HA., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Identifying key risk factors for premature discontinuation of opioid use disorder treatment in the United States: A predictive modeling study. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Perspectives of Patients Receiving Telemedicine Services for Opioid Use Disorder Treatment: A Qualitative Analysis of User Experiences. [2023]