NCT04380116: Soberlink

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

Completed NA Results posted Last updated 26 May 2023

What this trial tests

NA trial testing Soberlink in Alcohol Use Disorder in 96 participants. Completed in 1 May 2022.

Timeline

29 June 2020

Primary endpoint
1 May 2022

1 May 2022

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	29 June 2020
Primary completion	1 May 2022
Estimated completion	1 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Soberlink

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Yale University

Who can join

Adults 21 to 60, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Alcohol Time Line Follow Back (TLFB) Primary · 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).

Group	Value	95% CI
Sb+Aware	27.1	± 2.2
Aware	21	± 3.1

Quality of Life Survey Secondary · 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.

Group	Value	95% CI
Sb+Aware	73.53	± 26.3
Aware	75.9	± 23.2

Mean Positive BAC Response With Soberlink Secondary · 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.

Group	Value	95% CI
Sb+Aware	1.09	± 1.4

Alcohol Abstinence Self-efficacy Scale for Temptation. Secondary · 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

Group	Value	95% CI
Sb+Aware	20.5	± 18.5
Aware	20.1	± 19.4

Alcohol Abstinence Self-efficacy Scale for Confidence Secondary · 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.

Group	Value	95% CI
Sb+Aware	50.2	± 27.5
Aware	46.3	± 27.1

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility of a remotely monitored blood alcohol concentration device to facilitate treatment motivation.
   Buono FD, Polonsky M, Sprong ME, Aviles A, et al · · 2023 · cited 3× · PMID 38045492 · DOI 10.1016/j.dadr.2023.100202
2. Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial.
   Buono FD, Gleed C, Boldin M, Aviles A, et al · · 2022 · cited 1× · PMID 35029534 · DOI 10.2196/30186