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

Trial Summary

What is the purpose of this trial?

Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (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 data supports the effectiveness of the KIOS App treatment for opioid use disorder?

Research shows that digital tools like mobile apps can help people with opioid use disorder by providing accessible and cost-effective support, improving knowledge about treatment options, and increasing motivation to change. Computer-based interventions have been found to reduce substance use and improve treatment retention compared to usual care. ^{1 2 3 4 5}

Is the KIOS App safe for use in humans?

The research does not provide specific safety data for the KIOS App, but a similar app called OpPill was rated highly for ease of use and relevance by patients with sickle cell disease, suggesting it was well-received and did not raise safety concerns in that context. ^{1 2 3 6 7}

How is the KIOS App treatment different from other treatments for opioid use disorder?

The KIOS App is a digital therapeutic tool that offers a web-based self-management intervention, making it unique by providing accessible, low-cost support for individuals with opioid use disorder, unlike traditional face-to-face treatments. ^{1 2 3 8 9}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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 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]

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]

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]

References

1. 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]

2. England 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. [2022]

3. 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]

4. 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]

5. United States pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Quality Validation of a Mobile Application for Enhancing Adherence to Opioids in Sickle Cell Disease. [2022]

7. New Zealand 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. [2022]

8. United States 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. [2022]

9. 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]