Soberlink Within In-Home Addiction Treatment Program

NCT ID: NCT03902171

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2020-09-05

Brief Summary

The purpose of this study is to evaluate the impact of use of Soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an In-Home Addiction Treatment program. Treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. Although not the primary focus, recidivism and relapse will be measured.

Detailed Description

The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and who are enrolled in Aware Recovery Care's In-Home Addiction Treatment program where Care Teams will monitor cloud-based breathalyzer results. Soberlink's cloud-based breathalyzer system will provide data to Care Team if the Client has relapsed or is not compliant with testing through the Soberlink System. Clients will use Soberlink for 180 days within context of routine alcohol use disorder treatment at Aware Recovery Care.

Conditions

Alcohol Use Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary diagnosis alcohol use disorder (AUD)

Primary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program.

Soberlink

Intervention Type: DEVICE

Soberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes.

Secondary diagnosis alcohol use disorder (AUD)

Secondary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program.

Soberlink

Intervention Type: DEVICE

Soberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes.

Interventions

Soberlink

Soberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female subject between ages of 21-75 years old
• Subject active in In-Home Addiction Treatment Program (Aware Recovery Care)
• Subject admitted to program with American Society of Addiction Medicine (ASAM) Assessment score 1.5-2.5
• Primary or secondary diagnosis is alcohol use disorder
• Subject is willing to use Soberlink Device to provide Blood Alcohol Content (BAC)
• Subject is willing to discuss Soberlink test results with Care Team
• Subject is willing to sign Soberlink Client Agreement
• Subject is English speaking and reading

Exclusion Criteria

• Alcohol use disorder is not a primary or secondary diagnosis
• Subject is not between ages of 21 and 75 years old
• Subject is currently taking anti-alcohol/craving medications (Antabuse, Campral, Vivitrol)
• 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 involving depersonalization or active psychotic symptoms
• Active withdrawal/alcohol use within 72 hours of start of participation
• Subject is using Soberlink data for a child custody or legal consequence

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soberlink Healthcare LLC

INDUSTRY

Sponsor Role: collaborator

In-Home Addiction Treatment Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Courtney MacNeill, LMSW

Role: PRINCIPAL_INVESTIGATOR

Research Associate

Locations

Aware Recovery Care

North Haven, Connecticut, United States

Aware Recovery Care

Bedford, New Hampshire, United States

Countries

United States

Other Identifiers

SLIHAT-2019

Identifier Type: -

Identifier Source: org_study_id