Soberlink Within In-Home Addiction Treatment Program

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03902171
• Other study ID #: SLIHAT-2019
• Status: Enrolling by invitation
• Start date: April 2, 2019
• Est. completion date: September 5, 2020

Study information

• Verified date: April 2019
• Source: In-Home Addiction Treatment Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 5, 2020
• Est. primary completion date: February 28, 2020
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
United States	Aware Recovery Care	Bedford	New Hampshire
United States	Aware Recovery Care	North Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
In-Home Addiction Treatment Institute, Inc.	Soberlink Healthcare LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Retention in Treatment	Participation in In-Home Addiction Treatment program using length of stay reports.	180 days duration of subject participation
Primary	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
Primary	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
Primary	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	Relapse Rates	Occurrence of alcohol use	Measured throughout 180 days duration of subject participation
Secondary	Compliance with Testing	Occurrence of Missed Tests	Measured throughout 180 days duration of subject participation
Secondary	Hospitalization	Occurrence of Emergency Room and Inpatient hospital admissions	Measured throughout 180 days duration of subject participation
Secondary	Detox and Residential Admissions	Occurrence of residential treatment and detox admissions	Measured throughout 180 days duration of subject participation