mHealth for Patient Self-Management of Opioid Use Disorder

NCT ID: NCT03633929

Last Updated: 2023-04-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-08

Study Completion Date

2020-09-30

Brief Summary

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Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.

Detailed Description

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Participants will be enrolled in a 4-week single group pre-post evaluation. All participants will attend a two hour orientation to complete baseline assessments, learn how to access and use the software, and participate in a training session. Study participants will be asked to complete assessments online at least three times per week, but no more than once daily. The software may still be accessed by participants as many times as desired to review advice and graphs. After the four week evaluation phase, participants will return for a two hour debriefing and completion of assessment surveys. This approach permits users to be adequately trained while also evaluating the software within their typical environment rather than in a lab setting.

Conditions

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Opioid-use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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KIOS OUD

KIOS OUD

Intervention Type OTHER

Study Participants will evaluate software known as KIOS-OUD

Interventions

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KIOS OUD

Study Participants will evaluate software known as KIOS-OUD

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. male or female outpatients 18 years of age or older;
2. opioid use disorder as assessed by MINI 6.0;
3. currently stable in OUD outpatient treatment for 4 weeks or longer; and
4. ability to access KIOS-OUD via computer, smartphone, or tablet.

Exclusion Criteria

1. are unwilling or unable to comply with study requirements;
2. have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomedical Development Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karla Ramirez, LCSW

Role: PRINCIPAL_INVESTIGATOR

Consultant

Locations

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Biomedical Development Corporation

San Antonio, Texas, United States

Site Status

Community Medical Services

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2018-1-100-OUD

Identifier Type: -

Identifier Source: org_study_id

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