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

Yale University

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Device: Soberlink

Study type: Interventional

Funder types: Other

Identifiers

NCT04380116

2000027787

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Sb+Aware

Experimental group

Description:

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

Treatment:

Device: Soberlink

Aware

No Intervention group

Description:

Patients will only have access to Aware Recovery Care