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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Device: Soberlink


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 
| 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 | 
| 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 |