Trial Outcomes & Findings for Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality (NCT NCT04380116)

Last Updated: 2023-05-26

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

up to 24 weeks

Results posted on

2023-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Aware Patients will only have access to Aware Recovery Care
Overall Study STARTED	48	48
Overall Study COMPLETED	43	32
Overall Study NOT COMPLETED	5	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sb+Aware n=43 Participants 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.	Aware n=32 Participants Patients will only have access to Aware Recovery Care	Total n=75 Participants Total of all reporting groups
Work Status Retired	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Work Status Unemployed	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Generalized Anxiety Disorder-7 questionnaire	14.8 score on a scale STANDARD_DEVIATION 4.3 • n=5 Participants	15.3 score on a scale STANDARD_DEVIATION 6.1 • n=7 Participants	15.1 score on a scale STANDARD_DEVIATION 5.8 • n=5 Participants
Age, Continuous	48.6 years STANDARD_DEVIATION 10.5 • n=5 Participants	44.1 years STANDARD_DEVIATION 11.8 • n=7 Participants	45.04 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized White	34 Participants n=5 Participants	22 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	32 participants n=7 Participants	75 participants n=5 Participants
Marital Status Single	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Marital Status Married	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants
Marital Status Divorced	10 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants
Marital Status Separated	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Marital Status Widowed	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Highest Level of Education Completed High School	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Highest Level of Education Completed Some College	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Highest Level of Education Completed Associates	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Highest Level of Education Completed Bachelors	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Highest Level of Education Completed Advanced Degree	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Work Status Employed	33 Participants n=5 Participants	27 Participants n=7 Participants	60 Participants n=5 Participants
Work Status Student	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Patient Health Questionnaire-9 (PHQ-9)	13.3 units on a scale STANDARD_DEVIATION 5.5 • n=5 Participants	12.6 units on a scale STANDARD_DEVIATION 4.8 • n=7 Participants	12.9 units on a scale STANDARD_DEVIATION 5.8 • n=5 Participants
Previous Alcohol Treatments	3.1 mean number of participants STANDARD_DEVIATION 2.2 • n=5 Participants	2.9 mean number of participants STANDARD_DEVIATION 1.8 • n=7 Participants	3.02 mean number of participants STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: up to 24 weeks

Outcome measures

Outcome measures
Measure	Sb+Aware n=43 Participants 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.	Aware n=32 Participants Patients will only have access to Aware Recovery Care
Alcohol Time Line Follow Back (TLFB)	27.1 drinks per month Standard Deviation 2.2	21 drinks per month Standard Deviation 3.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sb+Aware n=43 Participants 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.	Aware n=32 Participants Patients will only have access to Aware Recovery Care
Quality of Life Survey	73.53 score on a scale Standard Deviation 26.3	75.9 score on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sb+Aware n=43 Participants 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.	Aware Patients will only have access to Aware Recovery Care
Mean Positive BAC Response With Soberlink	1.09 Positive responses Standard Deviation 1.4	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Sb+Aware n=43 Participants 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.	Aware n=32 Participants Patients will only have access to Aware Recovery Care
Alcohol Abstinence Self-efficacy Scale for Temptation.	20.5 score on a scale Standard Deviation 18.5	20.1 score on a scale Standard Deviation 19.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sb+Aware n=43 Participants 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.	Aware n=32 Participants Patients will only have access to Aware Recovery Care
Alcohol Abstinence Self-efficacy Scale for Confidence	50.2 score on a scale Standard Deviation 27.5	46.3 score on a scale Standard Deviation 27.1

Adverse Events

Sb+Aware

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aware

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Frank Buono

Yale University

Phone: 2037795799

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place