Soberlink Within In-Home Addiction Treatment Program

NCT03902171 | Unknown DMC FDA Device

• 1 other identifier: SLIHAT-2019
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Relapse Rates

  Measured throughout 180 days duration of subject participation

• Compliance with Testing

  Measured throughout 180 days duration of subject participation

• Hospitalization

  Measured throughout 180 days duration of subject participation

• Detox and Residential Admissions

  Measured throughout 180 days duration of subject participation

Study Arms (2)

Primary diagnosis alcohol use disorder (AUD)

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

Device: Soberlink

Secondary diagnosis alcohol use disorder (AUD)

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

Device: Soberlink

Interventions

Soberlink 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.

Primary diagnosis alcohol use disorder (AUD); Secondary diagnosis alcohol use disorder (AUD)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• In-Home Addiction Treatment Institute, Inc.: lead
• Soberlink Healthcare LLC: collaborator

Study Sites (2)

Aware Recovery Care

North Haven, Connecticut, 06473, United States

Location

Aware Recovery Care

Bedford, New Hampshire, 03111, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Courtney MacNeill, LMSW

  Research Associate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: April 2, 2019
• Primary Completion: February 28, 2020
• Study Completion: September 5, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)