Ambulatory Alcohol Detoxification With Remote Monitoring

Stanford University

Status

Withdrawn

Conditions

Alcohol Use Disorder

Treatments

Device: Remote Monitoring with Ambulatory Detox

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03582150

IRB-44681

Details and patient eligibility

About

This study is designed to examine the feasibility and impact of the use of remote monitoring devices during an outpatient ambulatory alcohol detoxification treatment for patients with alcohol use disorders.

Full description

The study will include 30 subjects with a diagnosis of alcohol use disorder. The study uses a breathalyzer device with facial recognition to confirm the patient's identity and sends the information to the study staff using cellular technology. A second device is used which is a wireless blood pressure cuff that connects to the patient's smartphone and sends blood pressure and heart rate measurements directly to the study physician for enhanced monitoring during alcohol withdrawal management. The duration of the study is 8 days, starting with an initial appointment to set up the equipment. Throughout the study, surveys are completed by subjects in regards to their experience with the device. Subjects undergo a brief 30-60 minute appointment on the first day of the study, appointments as needed throughout the study, and an appointment on the last day of the study to check in with the physician for ongoing ambulatory management of alcohol withdrawal, including medication adjustments if indicated.

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female Subject between the ages of 21-75 years old
Meeting DSM-V criteria for alcohol use disorder and needing medically supervised detoxification based on medical history and pattern of alcohol use delineated by timeline follow back method.
Has 24/7 easy access to a hospital. This is to ensure easy admission to a higher level of care if indicated.
Willing to use the Soberlink Device to provide blood alcohol concentration (BAC)
Willing to use the blood pressure cuff to provide blood pressure and pulse (BPPT) measurement
Willing to sign an informed consent

Exclusion criteria

BAC above the legal driving limit at the time of screening
Developing symptoms or history of symptoms of severe withdrawal syndrome such as fever, disorientation, drenching sweats, severe tachycardia, or severe hypertension
History of delirium tremens or seizures
Co-morbid medical or psychiatric history requiring inpatient admission for careful monitoring
Subject unwilling to respond to redirection when blood pressure and heart rate warning signs are triggered
Does not have an iPhone, iPod, iPad, or Apple Watch with iOS 7.0 or later, or does not have an Android phone or tablet with Android 4.4 or later
Unable or unwilling to properly use the monitoring devices, or find the monitoring devices an obstruction to comply with treatment
Subject that is non-English speaking
Subject that is a child, adolescent, or cognitively impaired