Opioid Use Disorder
Conditions
Keywords
Digital health therapeutic, Behavioral intervention strategies, Clinic-based counseling
Brief summary
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.
Interventions
DEVICEKIOS App
KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT)
BEHAVIORALKIOS App education
Educational tools provided to participants with opioid use disorder
BEHAVIORALTreatment as usual
Behavioral counseling in clinic
Sponsors
The University of Texas Health Science Center at San Antonio
National Institute on Drug Abuse (NIDA)
Biomedical Development Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Randomization will be stratified by two characteristics: (1) history of MOUD and (2) stimulant use in past one month. Allocation to treatment groups will be randomly assigned by 1:1 allotment to either KIOS + TAU (treatment as usual) or KIOS sham + TAU with strata. Study staff will be blind to the condition to which the participant is assigned.
Intervention model description
Randomized controlled 2 arm trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female outpatients 18 years of age or older 2. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. 3. DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder 4. Ability to access KIOS via smartphone or tablet 5. Recently (less than 6 months) enrolled in and currently participating in MOUD at a clinic in Texas
Exclusion criteria
1. Unwilling or unable to comply with study requirements 2. Psychiatric or medical disorder interfering with ability to use the app 3. Incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of opioid use reduction | 60 days to 13 weeks | 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 |
| Percentage of Opioid Abstinent Days | Baseline to 13 weeks | Total abstinence, measured by urinalysis confirmed self-report of opioid use during the 13-week intervention |
| Completion of treatment | Baseline to 13 weeks | Number of subjects that completed their participation in the study |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline and 13 weeks | 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. |
| Treatment Effectiveness Assessment TEA) | Baseline and 13 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Potter, PhD, MPH
The University of Texas Health Science Center at San Antonio
PRINCIPAL_INVESTIGATORElise Marino, PhD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed