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Soberlink Within In-Home Addiction Treatment Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902171
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Soberlink Healthcare LLC
Information provided by (Responsible Party):
In-Home Addiction Treatment Institute, Inc.

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.

Condition or disease Intervention/treatment
Alcohol Use Disorder 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes Related to Use of Soberlink Within In-Home Addiction Treatment Program for Individuals With Alcohol Use Disorder
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : September 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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.




Primary Outcome Measures :
  1. Rate of Retention in Treatment [ Time Frame: 180 days duration of subject participation ]
    Participation in In-Home Addiction Treatment program using length of stay reports.

  2. Brief Addiction Monitor questionnaire [ Time Frame: Conducted monthly throughout 180 days duration of subject participation ]
    Measure change in client report of symptoms related to alcohol use disorder

  3. Positive Outcomes Measures Survey [ Time Frame: Completed at week 3 or 4 and Week 20 during 180 days duration of subject participation ]
    Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no answer key

  4. Client Survey Related to use of Soberlink [ Time Frame: Completed at end of 180 days duration of subject participation ]
    Measures self-report of quality of life and experience with device using 5-point Likert scale (minimum Strongly Disagree, maximum Strongly Agree)


Secondary Outcome Measures :
  1. Relapse Rates [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of alcohol use

  2. Compliance with Testing [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of Missed Tests

  3. Hospitalization [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of Emergency Room and Inpatient hospital admissions

  4. Detox and Residential Admissions [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of residential treatment and detox admissions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902171


Locations
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United States, Connecticut
Aware Recovery Care
North Haven, Connecticut, United States, 06473
United States, New Hampshire
Aware Recovery Care
Bedford, New Hampshire, United States, 03111
Sponsors and Collaborators
In-Home Addiction Treatment Institute, Inc.
Soberlink Healthcare LLC
Investigators
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Principal Investigator: Courtney MacNeill, LMSW Research Associate
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Responsible Party: In-Home Addiction Treatment Institute, Inc.
ClinicalTrials.gov Identifier: NCT03902171    
Other Study ID Numbers: SLIHAT-2019
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders