Ambulatory Alcohol Detoxification With Remote Monitoring

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Primary Purpose

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Remote Monitoring with Ambulatory Detox

About this trial

This is an interventional supportive care trial for Alcohol Use Disorder focused on measuring Ambulatory alcohol detoxification, alcohol withdrawal, remote monitoring with breathalyzer

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Stanford Addiction Medicine and Dual Diagnosis Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Receiving Soberlink Device

Arm Description

Outcomes

Primary Outcome Measures

Number of participants completing the eight-day protocol using Soberlink Device

The Subject will be enrolled on day one and return to the site for an evaluation by the study staff on day eight. They will be seen by study staff as needed throughout the study for withdrawal management. If Subject complies with the guidelines of the study, medications will be prescribed. On or after the last day of the study, the Subject will return to the study site for a final evaluation outcomes.

Secondary Outcome Measures

Missed Soberlink test

If a scheduled Soberlink test is missed, Contacts will be notified. It is encouraged that the Subject submits an unscheduled test as soon as possible. If tests are repeatedly missed, the physician on duty will make a clinical determination whether to continue treatment, modify the treatment protocol, or advise transitioning to inpatient treatment immediately.

Positive BAC test received from Soberlink

If a positive BAC test is received, contacts will be notified. The Soberlink System will automatically engage the Subject in a Retest cycle. The Device screen will prompt the Subject to Retest in 15 minutes, and the Subject will receive an automated text message to their mobile phone informing them that because they submitted a positive test, they are now in a Retest cycle. If the confirmation test has a positive BAC, the Subject will be asked to Retest every 15 minutes until a compliant test is submitted, or until 3 hours have elapsed. Failing to follow the on-screen instructions and text message reminders will be considered noncompliance and a violation of the protocol.

Scheduled Blood pressure and heart rate test is missed or out of range

If a scheduled test is missed, it is encouraged that the Subject submits an unscheduled test as soon as possible. If tests are repeatedly missed, the physician on duty will make a clinical determination whether to continue treatment, modify the treatment protocol, or advise transitioning to inpatient treatment immediately.

Subject's self-report on effect of breathalyzer device on their behavior

Subjects will fill out surveys on the effect of using the device on their cravings and relapse.

Adverse events

If Subject experiences any adverse events, the Subject should contact the study staff, or call 9-1-1. The physician on duty will make a clinical determination whether to continue treatment, modify the treatment protocol, or advise transitioning to inpatient treatment immediately.

Subject not agreeable to clinical recommendations

If the Subjects are not agreeable to clinical recommendations, treatment will be discontinued and considered against advice. The Subject will be removed from the study, and no further clinical action will be taken. The Subject can always reconsider and return to the hospital for review of appropriate level of care.

Full Information

NCT ID

NCT03582150

First Posted

June 27, 2018

Last Updated

December 13, 2022

Sponsor

Stanford University

Collaborators

SoberLink, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03582150

Brief Title

Ambulatory Alcohol Detoxification With Remote Monitoring

Official Title

Ambulatory Alcohol Detoxification With Remote Monitoring

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Funding lost during COVID

Study Start Date

July 3, 2018 (Actual)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

SoberLink, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

Ambulatory alcohol detoxification, alcohol withdrawal, remote monitoring with breathalyzer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Receiving Soberlink Device

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Remote Monitoring with Ambulatory Detox

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants completing the eight-day protocol using Soberlink Device

Description

The Subject will be enrolled on day one and return to the site for an evaluation by the study staff on day eight. They will be seen by study staff as needed throughout the study for withdrawal management. If Subject complies with the guidelines of the study, medications will be prescribed. On or after the last day of the study, the Subject will return to the study site for a final evaluation outcomes.

Time Frame

Baseline to end of study (eight days).

Secondary Outcome Measure Information:

Title

Missed Soberlink test

Description

If a scheduled Soberlink test is missed, Contacts will be notified. It is encouraged that the Subject submits an unscheduled test as soon as possible. If tests are repeatedly missed, the physician on duty will make a clinical determination whether to continue treatment, modify the treatment protocol, or advise transitioning to inpatient treatment immediately.

Time Frame