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

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:

1. To determine the effectiveness of Soberlink's ability to increase abstinence
2. To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety.
3. 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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Device: Soberlink

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • North Haven, Connecticut, United States, 06517
      • Aware Recovery Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 58 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sb+Aware; Patients will access to the Soberlink device and receive treatment with Aware Recovery Care	Device: Soberlink; 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.
No Intervention: Aware; Patients will only have access to Aware Recovery Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 24 weeks
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	up to 24 weeks
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.	up to 24 weeks
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.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Yale University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 2000027787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes