Opioid Use DisorderNCT07348796
Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD
A study testing KIOS App in people with Opioid Use Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The researchers will study the KIOS app, a digital health tool made to help people recovering from opioid addiction take better care of themselves. They want to see how the app works in real life and learn who benefits most from using it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- KIOS App
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients 18 years of age or older
- DSM-5 criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Initiated buprenorphine treatment in the past 6 months
Who cannot join
- Unwilling or unable to comply with study requirements
- A psychiatric or medical condition interfering with ability to use the app
- Incarceration
- Suicide risk as determined by the treating medical clinician at the site
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas, 78229
About this study
Official title: Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for Opioid Use Disorder (OUD)
The researchers will study the KIOS app, a digital health tool made to help people recovering from opioid addiction take better care of themselves. They want to see how the app works in real life and learn who benefits most from using it. The study will also ask participants what they think about the app and how easy it is to use.
Read the detailed description
Participation in the study will last 12 months. Participants will be asked to complete assessments at 33 timepoints over the 12-month trial. This will include 1 screening assessment, 24 weekly assessments, 6 monthly assessments, and 2 follow-up assessments. All study assessments will be completed remotely.
Staff at each site will identify potential participants being treated with buprenorphine for opioid use disorder at their respective site. Providers will introduce the study and if interested, the participant will complete a screening assessment conducted by trained study staff to determine eligibility for the study.
Participants who are eligible will be enrolled into the study and given access to the KIOS app.
The active phase will include the first 6 months during which time participants will use the app, complete monthly assessments, and complete a weekly craving assessment. The second 6 months in the study will include two follow-up assessments at 9 months and 12 months post study start. At the end of the 12 months, app access will be removed. The follow up assessments will include the monthly assessments that were completed during the active phase, as well as the craving assessment. All assessments will be sent to the participants' email address for them to complete on any device with internet access. At the conclusion of 12 months of study participation, focus groups will be conducted with 25 of the participants to gather information about their perspectives on the app and its usability and features.
- Conditions
- Opioid Use Disorder
- Being tested
- KIOS App
- Keywords
- KIOS app, Digital health, Real-world impact
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIOS AppDevice
A digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS offers individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual and KIOS app | Experimental | Participants will be set up onto their preferred device(s) with assistance from a research assistant. KIOS will be accessible on all mobile devices as well as tablets. Treatment as usual (TAU) will be administered to all participants. Receives: Device: KIOS App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.
Measured: Baseline to 1 year
Secondary outcomes (7)
Diagnostic Statistical Manual Version 5 (DSM-5)
DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress
Measured: Baseline to 12 months
Opioid Craving Scale
A brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analog scale from 0-10. Items are as follows: 1) How much do you currently crave opiates?; 2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates?; and 3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today. The total scores range from 3-30 with a higher score indicating more opioid craving.
Measured: Baseline to 12 months
Patient Health Questionnaire-9 (PHQ-9)
A self-administered 9-item depression module that scores each of the 9 DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition). Items are score 0 to 3, providing a 0 to 27 severity score. Scores of 5, 10, 15, and 20 represent cutoff points for mild, moderate, moderately severe, and severe depression, respectively.
Measured: Baseline to 12 months
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7)13 measures anxiety with 7 items scored from 0 to 3, providing a 0 to 21 severity score. Scores of 5, 10, and 15 represent cutoff points for mild, moderate, and severe anxiety, espectively.
Measured: Baseline to 12 months
Treatment Progress and Recovery (TEA)
The TEA gauges progress in treatment and recovery within four domains established by prior research: substance use, health (physical or emotional), lifestyle (housing/living situation, family, employment, relationships), and community (obeying laws, responsible member of society). For each area, the patient is asked to think about how much better things have become on a 10-point scale (1 = not better at all and 10 = very much better). Scores range between 0-40, with a higher score indicating greater progress in treatment and recovery
Measured: 6 to 12 months
System Usability Scale (SUS)
The System Usability Scale (SUS)15 is a 10-item measure for assessing a system's usability on a 5-point Likert scale from strongly agree to strongly disagree. Scores are converted to a 100-point scale. A score above a 68 would be considered above average usability.
Measured: 6 months
KIOS User Satisfaction Survey
Participants complete a survey specific to KIOS regarding: (1) the content, appropriateness, and relevance of the advice; (2) enhancement of self-management skills; (3) selfawareness; and (4) overall satisfaction with health. Survey items will be answered with level of agreement with a given statement recorded on a Likert-type 0 (Disagree) - 7 (Agree) scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One Arm open-label efficacy study
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Biomedical Development Corporation
- Responsible party
- Principal investigator, Elise Marino, The University of Texas Health Science Center at San Antonio
- Investigators
- Elise Marino, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348796
- Sponsor's protocol ID
- STUDY00002308
- Other IDs
- 4R44DA059017-02
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT07348796
- Acronym / sponsor ID
- STUDY00002308
- Conditions
- Opioid Use Disorder
- Keywords
- KIOS app, Digital health, Real-world impact
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Biomedical Development Corporation
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Jan 2026 (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.
The researchers will study the KIOS app, a digital health tool made to help people recovering from opioid addiction take better care of themselves. They want to see how the app works in real life and learn who benefits most from using it. The study will also ask participants what they think about the app and how easy it is to use.
Detailed description
Participation in the study will last 12 months. Participants will be asked to complete assessments at 33 timepoints over the 12-month trial. This will include 1 screening assessment, 24 weekly assessments, 6 monthly assessments, and 2 follow-up assessments. All study assessments will be completed remotely.
Staff at each site will identify potential participants being treated with buprenorphine for opioid use disorder at their respective site. Providers will introduce the study and if interested, the participant will complete a screening assessment conducted by trained study staff to determine eligibility for the study.
Participants who are eligible will be enrolled into the study and given access to the KIOS app.
The active phase will include the first 6 months during which time participants will use the app, complete monthly assessments, and complete a weekly craving assessment. The second 6 months in the study will include two follow-up assessments at 9 months and 12 months post study start. At the end of the 12 months, app access will be removed. The follow up assessments will include the monthly assessments that were completed during the active phase, as well as the craving assessment. All assessments will be sent to the participants' email address for them to complete on any device with internet access. At the conclusion of 12 months of study participation, focus groups will be conducted with 25 of the participants to gather information about their perspectives on the app and its usability and features.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One Arm open-label efficacy study
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual and KIOS app | Experimental | Device: KIOS AppParticipants will be set up onto their preferred device(s) with assistance from a research assistant. KIOS will be accessible on all mobile devices as well as tablets. Treatment as usual (TAU) will be administered to all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients 18 years of age or older
- DSM-5 criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Initiated buprenorphine treatment in the past 6 months
Key exclusion criteria (4 listed)
- Unwilling or unable to comply with study requirements
- A psychiatric or medical condition interfering with ability to use the app
- Incarceration
- Suicide risk as determined by the treating medical clinician at the site
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 |
|---|---|---|
| KIOS AppA digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS offers individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. | Device | Treatment as usual and KIOS app |
Primary outcome
Retention in treatment
Time frame: Baseline to 1 year
The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.
7 secondary outcomes
Diagnostic Statistical Manual Version 5 (DSM-5)
Time frame: Baseline to 12 months
Opioid Craving Scale
Time frame: Baseline to 12 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline to 12 months
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline to 12 months
Treatment Progress and Recovery (TEA)
Time frame: 6 to 12 months
System Usability Scale (SUS)
Time frame: 6 months
KIOS User Satisfaction Survey
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Elise Marino, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIOS App in people with Opioid Use Disorder, run by The University of Texas Health Science Center at San Antonio 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 4 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: opening soon, as of the sponsor's last update on 27 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise Marino, PhD ((210) 567-5399, marinoe@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in treatment (time frame: Baseline to 1 year). 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 27 Oct 2026.