Ambulatory Alcohol Detoxification With Remote Monitoring

NCT ID: NCT03582150

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2021-12-31

Brief Summary

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.

Detailed 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.

Conditions

Alcohol Use Disorder

Keywords

Ambulatory alcohol detoxification; alcohol withdrawal; remote monitoring with breathalyzer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Receiving Soberlink Device

Group Type: EXPERIMENTAL

Remote Monitoring with Ambulatory Detox

Intervention Type: DEVICE

• Each Subject willing to participate will sign an Informed Consent and will receive a Subject Number.
• Study staff will assist Subject in setting up the Soberlink Device as well as the Bluetooth enabled blood pressure cuff and Smartphone APP.
• Study staff documents Subject's resting and standing blood pressure and pulse to establish a safety range for the study.
• Subjects will use the blood pressure cuff and the Soberlink Device four times a day per a set schedule to determine blood pressure and pulse and blood alcohol concentration (BAC). Results will be sent to the Soberlink System for study staff to review.
• If the Subject misses a Soberlink test, tests positive for alcohol, or the identity cannot be approved, the staff will be immediately notified by the Soberlink System.
• The Subject will be enrolled on a Monday and evaluated by the study physician and return to the site for an evaluation by the study physician and staff on Tuesday, and a final assessment on Thursday.

Interventions

Remote Monitoring with Ambulatory Detox

• Each Subject willing to participate will sign an Informed Consent and will receive a Subject Number.
• Study staff will assist Subject in setting up the Soberlink Device as well as the Bluetooth enabled blood pressure cuff and Smartphone APP.
• Study staff documents Subject's resting and standing blood pressure and pulse to establish a safety range for the study.
• Subjects will use the blood pressure cuff and the Soberlink Device four times a day per a set schedule to determine blood pressure and pulse and blood alcohol concentration (BAC). Results will be sent to the Soberlink System for study staff to review.
• If the Subject misses a Soberlink test, tests positive for alcohol, or the identity cannot be approved, the staff will be immediately notified by the Soberlink System.
• The Subject will be enrolled on a Monday and evaluated by the study physician and return to the site for an evaluation by the study physician and staff on Tuesday, and a final assessment on Thursday.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SoberLink, LLC

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Anna Lembke

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amer Raheemullah, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Addiction Medicine and Dual Diagnosis Clinic

Stanford, California, United States

Countries

United States

Other Identifiers

IRB-44681

Identifier Type: -

Identifier Source: org_study_id