Opioid Use DisorderNCT06212557
KIOS Mobile App Evaluation
A study testing KIOS App, KIOS App education and Treatment as usual 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
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- KIOS App, KIOS App education and Treatment as usual
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 29 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female outpatients 18 years of age or older
- Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Recently (less than 6 months) enrolled in and currently participating in MOUD at a clinic in Texas
Who cannot join
- Unwilling or unable to comply with study requirements
- Psychiatric or medical disorder interfering with ability to use the app
- Incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas, 78229
About this study
Official title: Evaluation of KIOS in a 12-week Randomized Controlled Trial
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).
Read the detailed description
The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS will offer individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.
- Conditions
- Opioid Use Disorder
- Being tested
- KIOS App, KIOS App education, Treatment as usual
- Keywords
- Digital health therapeutic, Behavioral intervention strategies, Clinic-based counseling
- 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
Also called KIOS
KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT)
KIOS App educationBehavioural
Also called KIOS education
Educational tools provided to participants with opioid use disorder
Treatment as usualBehavioural
Also called TAU
Behavioral counseling in clinic
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment as Usual plus KIOS App | Experimental | Treatment as usual in clinics with the use of the KIOS App Receives: Device: KIOS App; Behavioral: Treatment as usual |
| Treatment as Usual plus KIOS education App | Sham comparator | Treatment as usual in clinics with the use of the KIOs education App (Sham) Receives: Behavioral: KIOS App education; Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Measured by the number of days from the start of the 13-week intervention until the participant either leaves the trial, or completes the trial
Measured: Baseline to 13 weeks
Secondary outcomes (5)
Measure of opioid use reduction
Defined as abstaining from opioids during the last week and for at least 2 of the previous 3 weeks of the third month of MOUD treatment
Measured: 60 days to 13 weeks
Percentage of Opioid Abstinent Days
Total abstinence, measured by urinalysis confirmed self-report of opioid use during the 13-week intervention
Measured: Baseline to 13 weeks
Completion of treatment
Number of subjects that completed their participation in the study
Measured: Baseline to 13 weeks
Patient Health Questionnaire-9 (PHQ-9)
A 9 item questionnaire scored from 0 (Not at all) to 4 (Nearly every day) with a potential score of 0-36 with a lower score indicating better health and emotional well-being.
Measured: Baseline and 13 weeks
Treatment Effectiveness Assessment TEA)
The TEA asks the participant to express the extent of changes for the better from your involvement in the program to this point (or how things are if it's your first TEA or baseline) in four areas: substance use, health, lifestyle, and community. For each area, think about how things have become better and circle the results on the scale below: the more you have improved, the higher the number -from 1 (not better at all) to 10 (very much better). Possible scores are between 1 and 40 with a lower score indicating a worse outcome.
Measured: Baseline and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start2 May 2024
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled 2 arm trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Biomedical Development Corporation
- Responsible party
- Sponsor
- Investigators
- Jennifer Potter, PhD, MPH, Principal investigator, The University of Texas Health Science Center at San AntonioElise Marino, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212557
- Sponsor's protocol ID
- HSC20210407H
- Other IDs
- R42DA054881
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This study will be conducted in accordance with the following publication and data sharing policies and regulations: National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of KIOS in a 12-week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06212557
- Acronym / sponsor ID
- HSC20210407H
- Conditions
- Opioid Use Disorder
- Keywords
- Digital health therapeutic, Behavioral intervention strategies, Clinic-based counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- 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
- 2 May 2024 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 19 Jan 2024 (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.
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).
Detailed description
The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS will offer individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled 2 arm trial
| Arm | Type | Receives |
|---|---|---|
| Active Treatment as Usual plus KIOS App | Experimental | Device: KIOS App, Behavioral: Treatment as usualTreatment as usual in clinics with the use of the KIOS App |
| Treatment as Usual plus KIOS education App | Sham comparator | Behavioral: KIOS App education, Behavioral: Treatment as usualTreatment as usual in clinics with the use of the KIOs education App (Sham) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatients 18 years of age or older
- Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Recently (less than 6 months) enrolled in and currently participating in MOUD at a clinic in Texas
Key exclusion criteria (3 listed)
- Unwilling or unable to comply with study requirements
- Psychiatric or medical disorder interfering with ability to use the app
- Incarceration
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 AppAlso: KIOSKIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT) | Device | Active Treatment as Usual plus KIOS App |
| KIOS App educationAlso: KIOS educationEducational tools provided to participants with opioid use disorder | Behavioural | Treatment as Usual plus KIOS education App |
| Treatment as usualAlso: TAUBehavioral counseling in clinic | Behavioural | Active Treatment as Usual plus KIOS App, Treatment as Usual plus KIOS education App |
Primary outcome
Retention in treatment
Time frame: Baseline to 13 weeks
Measured by the number of days from the start of the 13-week intervention until the participant either leaves the trial, or completes the trial
5 secondary outcomes
Measure of opioid use reduction
Time frame: 60 days to 13 weeks
Percentage of Opioid Abstinent Days
Time frame: Baseline to 13 weeks
Completion of treatment
Time frame: Baseline to 13 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 13 weeks
Treatment Effectiveness Assessment TEA)
Time frame: Baseline and 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. This study will be conducted in accordance with the following publication and data sharing policies and regulations: National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
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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.
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
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, KIOS App education and Treatment as usual 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 5 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: finished, as of the sponsor's last update on 13 Jul 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention in treatment (time frame: Baseline to 13 weeks). 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 13 Jul 2026.