mHealth for Patient Self-Management of Opioid Use Disorder

B

Biomedical Development Corporation

Status

Completed

Conditions

Opioid-use Disorder

Treatments

Other: KIOS OUD

Study type

Observational

Funder types

Industry

Identifiers

NCT03633929
2018-1-100-OUD

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

19 participants in 1 patient group

KIOS OUD
Treatment:
Other: KIOS OUD

Trial documents
3

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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