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KIOS Mobile App Evaluation

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ClinicalTrials.gov Identifier: NCT06212557
Recruitment Status : Recruiting
First Posted : January 19, 2024
Last Update Posted : May 22, 2024
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Biomedical Development Corporation
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Device: KIOS App Behavioral: KIOS App education Behavioral: Treatment as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled 2 arm trial
Masking: Single (Investigator)
Masking Description: Randomization will be stratified by three characteristics: (1) buprenorphine or methadone, (2) history of MAT, and (3) 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.
Primary Purpose: Treatment
Official Title: Evaluation of KIOS in a 12-week Randomized Controlled Trial
Actual Study Start Date : May 2, 2024
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : October 2025

Arm Intervention/treatment
Experimental: Active Treatment as Usual plus KIOS App
Treatment as usual in clinics with the use of the KIOS App
Device: KIOS App
KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT)
Other Name: KIOS

Behavioral: Treatment as usual
Behavioral counseling in clinic
Other Name: TAU

Sham Comparator: Treatment as Usual plus KIOS education App
Treatment as usual in clinics with the use of the KIOs education App (Sham)
Behavioral: KIOS App education
Educational tools provided to participants with opioid use disorder
Other Name: KIOS education

Behavioral: Treatment as usual
Behavioral counseling in clinic
Other Name: TAU




Primary Outcome Measures :
  1. Percentage of Opioid Abstinent Days [ Time Frame: Baseline to 12 weeks ]
    Total abstinence, measured by urinalysis confirmed self-report of opioid use during the 12-week intervention


Secondary Outcome Measures :
  1. Measure of opioid use reduction [ Time Frame: 60 days to 12 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 MAT treatment

  2. Retention in treatment [ Time Frame: Baseline to 12 weeks ]
    Measured by the number of days from the start of the 12-week intervention until the participant either leaves the trial, or completes the trial

  3. Completion of treatment [ Time Frame: Baseline to 12 weeks ]
    Number of subjects that completed their participation in the study

  4. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 12 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.

  5. Treatment Effectiveness Assessment TEA) [ Time Frame: Baseline and 12 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 MAT at a Be Well Texas (UT Health San Antonio) participating clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06212557


Contacts
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Contact: Jennifer Potter, PhD, MPH 210-562-5698 potterjs@uthscsa.edu
Contact: Tara Wright, PhD, MS 210-450-3903 WrightT3@uthscsa.edu

Locations
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United States, Texas
University of Texas Health Science Center - Department of Psychiatry Recruiting
San Antonio, Texas, United States, 78229
Contact: Tara Wright, PhD, MS    210-450-3903    WrightT3@uthscsa.edu   
Contact: Jessica Harrison, MS    210-450-3899    HarrisonJL@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institute on Drug Abuse (NIDA)
Biomedical Development Corporation
Investigators
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Principal Investigator: Jennifer Potter, PhD, MPH The University of Texas Health Science Center at San Antonio
Principal Investigator: Tara Wright, PhD, MS The University of Texas Health Science Center at San Antonio
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT06212557    
Other Study ID Numbers: HSC20210407H
R42DA054881 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2024    Key Record Dates
Last Update Posted: May 22, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After study completion and data analysis when summary results are posted on ClinicalTrials.gov and then after peer review and publication acceptance.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
Digital health therapeutic
Behavioral intervention strategies
Clinic-based counseling
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders