KIOS App for Opioid Use Disorder

Overseen By Elise Marino, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must be taking: MAT

Disqualifiers: Psychiatric disorder, Medical disorder, Incarceration

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: Unknown

Duration: 12 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a mobile app called KIOS in assisting people with opioid use disorder (OUD). Participants will either use the KIOS app alongside their usual treatment or continue with their regular treatment using a sham version of the app. The researchers aim to determine if the app can improve treatment outcomes. Ideal participants are those diagnosed with OUD, who can access the app on a smartphone or tablet, and are currently receiving medication treatment for OUD in a Texas clinic. As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment options for OUD.

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

The trial protocol does not specify if you need to stop your current medications. However, since participants must be currently enrolled in medication-assisted treatment (MAT), it seems you may need to continue your existing treatment.

What prior data suggests that the KIOS App is safe for treating opioid use disorder?

Research does not provide specific safety data for the KIOS App. However, a similar app, OpPill, proved safe and well-tolerated by users. This suggests that KIOS might also be safe for people. The trial's advanced stage indicates some confidence in its safety. Nonetheless, always consider this information carefully and consult healthcare professionals when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KIOS App for Opioid Use Disorder because it offers a new digital approach to support treatment. Unlike traditional methods such as medication-assisted treatment (MAT) with methadone or buprenorphine, the KIOS App provides educational resources and personalized support directly through a smartphone, making it more accessible and user-friendly. This app aims to enhance the standard care by integrating technology, which could improve patient engagement and adherence to treatment plans, potentially leading to better outcomes.

What evidence suggests that the KIOS App is effective for opioid use disorder?

Research shows that the KIOS app could be a helpful tool for managing opioid use disorder (OUD). In this trial, participants will join different treatment arms to evaluate its effectiveness. One arm will receive the KIOS App alongside standard care, while another will use the KIOS education App as a sham comparator with standard care. This app supports people in recovery by providing digital assistance alongside regular treatments. It allows users and healthcare providers to track progress through self-reported data. The aim is to improve recovery by giving users more control and understanding of their journey. Although direct evidence on its effectiveness is limited, the app is viewed as a digital health tool that might offer benefits when combined with other OUD treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer Potter, PhD, MPH

Principal Investigator

The University of Texas Health Science Center at San Antonio

Elise Marino, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid use disorder who can legally consent and communicate with the study team. Participants must have a smartphone or tablet to access the KIOS app and be recently enrolled in Medication-Assisted Treatment at a participating clinic. Those unable to follow study rules or with conditions that hinder app usage, as well as incarcerated individuals, cannot join.

Inclusion Criteria

Recently (less than 6 months) enrolled in and currently participating in MAT at a Be Well Texas (UT Health San Antonio) participating clinic

Must meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder

I can use a smartphone or tablet to access KIOS.

Exclusion Criteria

Incarceration

Presence of psychiatric or medical disorder interfering with ability to use the app

Unwilling or unable to comply with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the KIOS app alongside treatment as usual for opioid use disorder

12 weeks

Regular app usage and clinic visits as per usual care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KIOS App
• KIOS App education
• Treatment as usual

Trial Overview

The trial evaluates the effectiveness of the KIOS mobile medical app compared to standard treatment for opioid use disorder. It aims to see if using this educational app alongside usual care improves outcomes for patients managing their condition.

How Is the Trial Designed?

Group I: Active Treatment as Usual plus KIOS App Experimental Treatment 2 Interventions

Treatment as usual in clinics with the use of the KIOS App

Group II: Treatment as Usual plus KIOS education App Placebo Group 2 Interventions

Treatment as usual in clinics with the use of the KIOs education App (Sham)

KIOS App is already approved in United States for the following indications:

Approved in United States as KIOS App for:

• Opioid use disorder (OUD)

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Biomedical Development Corporation

Industry Sponsor

Trials

14

Recruited

880+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

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]

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]

Computer-based interventions for drug use disorders have shown high acceptability and can lead to reduced substance use, increased motivation to change, and better retention compared to traditional treatment methods, based on a review of 12 studies.

These interventions offer a promising alternative due to their lower cost and greater accessibility, suggesting they could significantly transform treatment approaches for drug use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. Moore, BA., Fazzino, T., Garnet, B., et al.[2022]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

A digital therapeutic (DT) significantly increased abstinence rates among patients with substance use disorders (40.3% in the DT group vs. 17.6% in the treatment-as-usual group) over a 12-week period, indicating its efficacy in reducing substance use.

The DT also improved retention in treatment (76.2% vs. 63.2%), and importantly, there were no significant differences in adverse event rates between the DT and traditional treatment groups, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. Maricich, YA., Nunes, EV., Campbell, ANC., et al.[2022]

The FAERS database revealed that opioids, particularly oxycodone, hydrocodone, and fentanyl, are frequently associated with adverse drug events (ADEs), with oxycodone alone accounting for over 158,000 reports, which is about 20.2% of all opioid-related reports.

Heroin had the highest proportion of deaths related to its use, with 71.8% of reports involving fatalities, highlighting the significant risks associated with opioid use, especially for certain drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioids and frequency counts in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database: a quantitative view of the epidemic. Veronin, MA., Schumaker, RP., Dixit, RR., et al.[2022]

The OpPill application was developed to enhance opioid adherence among patients with sickle cell disease (SCD) and was rated highly by users for its engagement, functionality, aesthetics, and information quality, indicating its potential effectiveness in monitoring opioid use.

In a study with 28 participants, 91.7% found the app relevant to their care, and 85.7% reported it as interesting to use, suggesting that mobile health technology can be a feasible and user-friendly tool for managing opioid adherence in chronic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Quality Validation of a Mobile Application for Enhancing Adherence to Opioids in Sickle Cell Disease. Sop, DM., Crouch, T., Zhang, Y., 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11019416/

Development and Evaluation of a Digital App for Patient ...

The KIOS software also provides analytics on the self-reported data that can be used by patients, clinicians, and researchers to track outcomes.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06212557

Study Details | NCT06212557 | KIOS Mobile App Evaluation

The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder ...

3.

withpower.com

withpower.com/trial/phase-opioid-related-disorders-1-2024-fa233

KIOS App for Opioid Use Disorder

Trial Overview The trial evaluates the effectiveness of the KIOS mobile medical app compared to standard treatment for opioid use disorder. It aims to see if ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38557501/

Development and Evaluation of a Digital App for Patient Self ...

The KIOS software also provides analytics on the self-reported data that can be used by patients, clinicians, and researchers to track outcomes.

5.

sbir.gov

sbir.gov/awards/193876

Award | SBIR

This project completes development of KIOS as a prescription digital health therapeutic suitable for FDA approval concomitant to MAT to treat OUD.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12334106/

Development of a Sham Smartphone App for Opioid Use ...

The study described here was designed to test the suitability of the KIOS sham app as a control condition for a randomized trial. A priori ...

7.

researchgate.net

researchgate.net/publication/379480307_Development_and_Evaluation_of_a_Digital_App_for_Patient_Self-Management_of_Opioid_Use_Disorder_Usability_Acceptability_and_Utility_Study

Development and Evaluation of a Digital App for Patient ...

The KIOS software also provides analytics on the self-reported data that can be used by patients, clinicians, and researchers to track outcomes. Results In a 4- ...