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Soberlink - MAP Outcomes Study Protocol

Soberlink - MAP Outcomes Study Protocol

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03190356
Enrollment
6
Registered
2017-06-16
Start date
2017-08-22
Completion date
2018-04-27
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Addiction

Brief summary

The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other means of mitigating recidivism and costly treatment episodes from AUD population.

Detailed description

The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels. Soberlink's remote alcohol system will provide data to inform the Case Manager if the Client has relapsed or is at risk of relapsing through the use of testing data compiled by the Soberlink System. Integrating Soberlink results into MAP's EMR will allow Case Manager to make better clinical decisions and reduce costs by mitigating the chances recidivism through early intervention. Clients will use the Soberlink Device for a period of 90 days.

Interventions

Soberlink Cellular Device delivers real-time blood alcohol results to people who support individuals in recovery. MAP platform helps monitor and support compliance with discharge plans while providing tools to improve outcomes for behavioral health diagnoses.

Sponsors

MAP Health Management LLC
CollaboratorUNKNOWN
Soberlink Healthcare LLC
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years

Inclusion criteria

* Male or female subject between ages of 21-65 years old * Subject is active in MAP's program with recovery support services * Subject has received acute professional treatment in the last 120 days * Primary or secondary diagnosis is Alcohol Use Disorder * Subject willing to use Soberlink Device to provide BAC * Subject is willing to discuss Soberlink test results with case manager * Subject is willing to sign a Soberlink Client Agreement * Subject is English speaking and reading

Exclusion criteria

* Alcohol Use Disorder is not a primary or secondary diagnosis * Subject is currently taking anti-alcohol medications * Subject will not be in the United States through duration of study * Subject is unwilling to properly use the device * Subject is non-English speaking and reading * Subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder, such as schizophrenia

Design outcomes

Primary

MeasureTime frameDescription
Recidivism90 days duration of subject participationDetermination of client relapse or risk of relapsing through the use of testing data compiled by the Soberlink Cellular Device

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026