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

Alcohol Use Disorder Clinical Trial

— Soberlink  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380116
• Other study ID #: 2000027787
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
United States	Aware Recovery Care	North Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	up to 24 weeks
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.	up to 24 weeks
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.	up to 24 weeks
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	up to 24 weeks
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.	up to 24 weeks

External Links

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