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 volunteersQualifiers
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
Single group
Treatments tested in this trial
KIOS App
DeviceA 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Diagnostic Statistical Manual Version 5 (DSM-5)
DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress
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.
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.
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.
Sponsors and contacts
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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: