Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • KIOS App

    Device

    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.

Treatment groups

134 Participants
are divided into 1 treatment group
Group A: Treatment as usual and KIOS appExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 1 year

Secondary outcomes

1

Diagnostic Statistical Manual Version 5 (DSM-5)

DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress

Time frame
Baseline to 12 months
2

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.

Time frame
Baseline to 12 months
3

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.

Time frame
Baseline to 12 months
4

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.

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Biomedical Development Corporation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: