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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.

Tracking Information
First Submitted Date April 1, 2019
First Posted Date April 3, 2019
Last Update Posted Date April 5, 2019
Actual Study Start Date April 2, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2019)
  • 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.
  • 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
  • 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
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 2, 2019)
  • Relapse Rates [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of alcohol use
  • Compliance with Testing [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of Missed Tests
  • Hospitalization [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of Emergency Room and Inpatient hospital admissions
  • Detox and Residential Admissions [ Time Frame: Measured throughout 180 days duration of subject participation ]
    Occurrence of residential treatment and detox admissions
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Alcohol Use Disorder
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.
Study Groups/Cohorts
  • Primary diagnosis alcohol use disorder (AUD)
    Primary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program.
    Intervention: Device: Soberlink
  • Secondary diagnosis alcohol use disorder (AUD)
    Secondary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program.
    Intervention: Device: Soberlink
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: April 2, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 5, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03902171
Other Study ID Numbers SLIHAT-2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party In-Home Addiction Treatment Institute, Inc.
Study Sponsor In-Home Addiction Treatment Institute, Inc.
Collaborators Soberlink Healthcare LLC
Investigators
Principal Investigator: Courtney MacNeill, LMSW Research Associate
PRS Account In-Home Addiction Treatment Institute, Inc.
Verification Date April 2019