Clinical trial NCT03902171: Soberlink Within In-Home Addiction Treatment Program
Official title: Outcomes Related to Use of Soberlink Within In-Home Addiction Treatment Program for Individuals With Alcohol Use Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Use Disorder
Lead sponsor: In-Home Addiction Treatment Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Soberlink Healthcare LLC
First posted: 2019-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Rate of Retention in Treatment
timeFrame: 180 days duration of subject participation
measure: Brief Addiction Monitor questionnaire
timeFrame: Conducted monthly throughout 180 days duration of subject participation
measure: Positive Outcomes Measures Survey
timeFrame: Completed at week 3 or 4 and Week 20 during 180 days duration of subject participation
measure: Client Survey Related to use of Soberlink
timeFrame: Completed at end of 180 days duration of subject participation
Secondary outcomes:
measure: Relapse Rates
timeFrame: Measured throughout 180 days duration of subject participation
measure: Compliance with Testing
timeFrame: Measured throughout 180 days duration of subject participation
measure: Hospitalization
timeFrame: Measured throughout 180 days duration of subject participation
measure: Detox and Residential Admissions
timeFrame: Measured throughout 180 days duration of subject participation
Other outcomes:
Locations:
city: North Haven
country: United States
facility: Aware Recovery Care
state: Connecticut
city: Bedford
country: United States
facility: Aware Recovery Care
state: New Hampshire
Study officials:
affiliation: Research Associate
name: Courtney MacNeill, LMSW
role: PRINCIPAL_INVESTIGATOR
References: