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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2022-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

NCT03883126

Alcohol Use Disorder

ACTIVE_NOT_RECRUITING NA

Attentional Control Training for Treating Alcohol Use Disorder

NCT05102942

Alcohol Use Disorder (AUD) Attentional Bias

RECRUITING NA

Brief Interventions for Drop-out Re-engagement

NCT00350571

Substance Abuse

COMPLETED PHASE1

Soberlink - MAP Outcomes Study Protocol

NCT03190356

Alcohol Addiction

TERMINATED

Accuracy & Usability Study for Soberlink Cellular Device

NCT02794038

Substance Abuse

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sb+Aware

Patients will access to the Soberlink device and receive treatment with Aware Recovery Care

Group Type EXPERIMENTAL

Soberlink

Intervention Type DEVICE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes