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Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality (Soberlink)

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soberlink
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • are at least 21 years old,
  • currently enrolled at Aware In home treatment,
  • Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD).

Exclusion Criteria:

  • Current suicide or homicide risk,
  • meet criteria for DSM-IV current psychotic disorder, or bipolar disorder,
  • does not have phone access with text message capabilities
  • Unable to read or understand English,
  • Unable to complete the study because of anticipated incarceration or move,
  • Life-threatening or unstable medical problems,
  • No course of current or pending legal action,
  • Soberlink results being used for child custody or legal circumstance.

Sites / Locations

  • Aware Recovery Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sb+Aware

Aware

Arm Description

Patients will access to the Soberlink device and receive treatment with Aware Recovery Care

Patients will only have access to Aware Recovery Care

Outcomes

Primary Outcome Measures

Alcohol Time Line Follow Back (TLFB)
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time (previous month). The Alcohol TLFB allows several dimensions of a person's drinking to be separately examined: (a) variability (i.e., scatter); (b) pattern (i.e., shape); and (c) extent of drinking (i.e., elevation; how much).

Secondary Outcome Measures

Quality of Life Survey
the quality of life survey (QLS) is a 16 question self-directed 7-point likert based survey (7-delighted; 1-terrible. The total score is 112, and the lowest is 16. Generally higher score indicate better QLS.
Mean Positive BAC Response With Soberlink
sensor to detect alcohol levels at an accuracy of +/-.005 BAC. BAC is established by the manufacturer based on predetermined cut off points. Mean number of positive responses, recorded using Soberlink sensor.
Alcohol Abstinence Self-efficacy Scale for Temptation.
Alcohol Abstinence Self-Efficacy Scale for Temptation is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Lower scores indicate that participants do not believe they can resist the temptation to drink alcohol
Alcohol Abstinence Self-efficacy Scale for Confidence
Alcohol Abstinence Self-Efficacy Scale for Confidence is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Higher scores indicate higher confidence in abstaining from alcohol.

Full Information

First Posted
April 29, 2020
Last Updated
May 24, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04380116
Brief Title
Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Acronym
Soberlink
Official Title
Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD). The specific AIMS will be: To determine the effectiveness of Soberlink's ability to increase abstinence To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety. To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for individuals who have had access to the Soberlink device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sb+Aware
Arm Type
Experimental
Arm Description
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Arm Title
Aware
Arm Type
No Intervention
Arm Description
Patients will only have access to Aware Recovery Care
Intervention Type
Device
Intervention Name(s)
Soberlink
Intervention Description
Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
Primary Outcome Measure Information:
Title
Alcohol Time Line Follow Back (TLFB)
Description
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time (previous month). The Alcohol TLFB allows several dimensions of a person's drinking to be separately examined: (a) variability (i.e., scatter); (b) pattern (i.e., shape); and (c) extent of drinking (i.e., elevation; how much).
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Survey
Description
the quality of life survey (QLS) is a 16 question self-directed 7-point likert based survey (7-delighted; 1-terrible. The total score is 112, and the lowest is 16. Generally higher score indicate better QLS.
Time Frame
up to 24 weeks
Title
Mean Positive BAC Response With Soberlink
Description
sensor to detect alcohol levels at an accuracy of +/-.005 BAC. BAC is established by the manufacturer based on predetermined cut off points. Mean number of positive responses, recorded using Soberlink sensor.
Time Frame
up to 24 weeks
Title
Alcohol Abstinence Self-efficacy Scale for Temptation.
Description
Alcohol Abstinence Self-Efficacy Scale for Temptation is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Lower scores indicate that participants do not believe they can resist the temptation to drink alcohol
Time Frame
up to 24 weeks
Title
Alcohol Abstinence Self-efficacy Scale for Confidence
Description
Alcohol Abstinence Self-Efficacy Scale for Confidence is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Higher scores indicate higher confidence in abstaining from alcohol.
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: are at least 21 years old, currently enrolled at Aware In home treatment, Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD). Exclusion Criteria: Current suicide or homicide risk, meet criteria for DSM-IV current psychotic disorder, or bipolar disorder, does not have phone access with text message capabilities Unable to read or understand English, Unable to complete the study because of anticipated incarceration or move, Life-threatening or unstable medical problems, No course of current or pending legal action, Soberlink results being used for child custody or legal circumstance.
Facility Information:
Facility Name
Aware Recovery Care
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35029534
Citation
Buono FD, Gleed C, Boldin M, Aviles A, Wheeler N. Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e30186. doi: 10.2196/30186.
Results Reference
derived
Links:
URL
http://www.soberlink.com
Description
Related Info

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Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality

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