Soberlink Within In-Home Addiction Treatment Program

Outcomes Related to Use of Soberlink Within In-Home Addiction Treatment Program for Individuals With Alcohol Use Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Device: Soberlink

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • North Haven, Connecticut, United States, 06473
      • Aware Recovery Care
  • New Hampshire
    • Bedford, New Hampshire, United States, 03111
      • Aware Recovery Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects are active participants in Aware Recovery Care, an In-Home Addiction Treatment program with an active primary or secondary diagnosis of alcohol use disorder.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary diagnosis alcohol use disorder (AUD); Primary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program.	Device: 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.
Secondary diagnosis alcohol use disorder (AUD); Secondary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Retention in Treatment	Participation in In-Home Addiction Treatment program using length of stay reports.	180 days duration of subject participation
Brief Addiction Monitor questionnaire	Measure change in client report of symptoms related to alcohol use disorder	Conducted monthly throughout 180 days duration of subject participation
Positive Outcomes Measures Survey	Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no answer key	Completed at week 3 or 4 and Week 20 during 180 days duration of subject participation
Client Survey Related to use of Soberlink	Measures self-report of quality of life and experience with device using 5-point Likert scale (minimum Strongly Disagree, maximum Strongly Agree)	Completed at end of 180 days duration of subject participation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse Rates	Occurrence of alcohol use	Measured throughout 180 days duration of subject participation
Compliance with Testing	Occurrence of Missed Tests	Measured throughout 180 days duration of subject participation
Hospitalization	Occurrence of Emergency Room and Inpatient hospital admissions	Measured throughout 180 days duration of subject participation
Detox and Residential Admissions	Occurrence of residential treatment and detox admissions	Measured throughout 180 days duration of subject participation

Collaborators and Investigators

• Sponsor: In-Home Addiction Treatment Institute, Inc.
• Collaborators: Soberlink Healthcare LLC
• Investigators: Principal Investigator: Courtney MacNeill, LMSW, Research Associate

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): September 5, 2020

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: SLIHAT-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No