Alcohol Use Disorder
Conditions
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: 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.
Interventions
DEVICESoberlink
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.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Time Line Follow Back (TLFB) | up to 24 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Survey | up to 24 weeks | 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 | up to 24 weeks | 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. | up to 24 weeks | 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 | up to 24 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sb+Aware Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
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. | 43 |
| Aware Patients will only have access to Aware Recovery Care | 32 |
| Total | 75 |
Baseline characteristics
| Characteristic | Total | Aware | Sb+Aware |
|---|---|---|---|
| Age, Continuous | 45.04 years STANDARD_DEVIATION 11.7 | 44.1 years STANDARD_DEVIATION 11.8 | 48.6 years STANDARD_DEVIATION 10.5 |
| Generalized Anxiety Disorder-7 questionnaire | 15.1 score on a scale STANDARD_DEVIATION 5.8 | 15.3 score on a scale STANDARD_DEVIATION 6.1 | 14.8 score on a scale STANDARD_DEVIATION 4.3 |
| Highest Level of Education Completed Advanced Degree | 20 Participants | 6 Participants | 14 Participants |
| Highest Level of Education Completed Associates | 2 Participants | 1 Participants | 1 Participants |
| Highest Level of Education Completed Bachelors | 22 Participants | 10 Participants | 12 Participants |
| Highest Level of Education Completed High School | 20 Participants | 9 Participants | 11 Participants |
| Highest Level of Education Completed Some College | 11 Participants | 6 Participants | 5 Participants |
| Marital Status Divorced | 11 Participants | 1 Participants | 10 Participants |
| Marital Status Married | 45 Participants | 19 Participants | 26 Participants |
| Marital Status Separated | 4 Participants | 2 Participants | 2 Participants |
| Marital Status Single | 14 Participants | 9 Participants | 5 Participants |
| Marital Status Widowed | 1 Participants | 1 Participants | 0 Participants |
| Patient Health Questionnaire-9 (PHQ-9) | 12.9 units on a scale STANDARD_DEVIATION 5.8 | 12.6 units on a scale STANDARD_DEVIATION 4.8 | 13.3 units on a scale STANDARD_DEVIATION 5.5 |
| Previous Alcohol Treatments | 3.02 mean number of participants STANDARD_DEVIATION 1.1 | 2.9 mean number of participants STANDARD_DEVIATION 1.8 | 3.1 mean number of participants STANDARD_DEVIATION 2.2 |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 22 Participants | 34 Participants |
| Region of Enrollment United States | 75 participants | 32 participants | 43 participants |
| Sex: Female, Male Female | 57 Participants | 27 Participants | 30 Participants |
| Sex: Female, Male Male | 18 Participants | 5 Participants | 13 Participants |
| Work Status Employed | 60 Participants | 27 Participants | 33 Participants |
| Work Status Retired | 5 Participants | 2 Participants | 3 Participants |
| Work Status Student | 1 Participants | 0 Participants | 1 Participants |
| Work Status Unemployed | 9 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 32 |
| other Total, other adverse events | 0 / 43 | 0 / 32 |
| serious Total, serious adverse events | 0 / 43 | 0 / 32 |
Outcome results
Primary
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).
Time frame: up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sb+Aware | Alcohol Time Line Follow Back (TLFB) | 27.1 drinks per month | Standard Deviation 2.2 |
| Aware | Alcohol Time Line Follow Back (TLFB) | 21 drinks per month | Standard Deviation 3.1 |
Secondary
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.
Time frame: up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sb+Aware | Alcohol Abstinence Self-efficacy Scale for Confidence | 50.2 score on a scale | Standard Deviation 27.5 |
| Aware | Alcohol Abstinence Self-efficacy Scale for Confidence | 46.3 score on a scale | Standard Deviation 27.1 |
Secondary
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
Time frame: up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sb+Aware | Alcohol Abstinence Self-efficacy Scale for Temptation. | 20.5 score on a scale | Standard Deviation 18.5 |
| Aware | Alcohol Abstinence Self-efficacy Scale for Temptation. | 20.1 score on a scale | Standard Deviation 19.4 |
Secondary
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.
Time frame: up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sb+Aware | Mean Positive BAC Response With Soberlink | 1.09 Positive responses | Standard Deviation 1.4 |
Secondary
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.
Time frame: up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sb+Aware | Quality of Life Survey | 73.53 score on a scale | Standard Deviation 26.3 |
| Aware | Quality of Life Survey | 75.9 score on a scale | Standard Deviation 23.2 |
p-value: 0.366ANOVA