Clinical trial NCT03582150: Ambulatory Alcohol Detoxification With Remote Monitoring
Official title: Ambulatory Alcohol Detoxification With Remote Monitoring
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Ambulatory alcohol detoxification
alcohol withdrawal
remote monitoring with breathalyzer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: SoberLink, LLC
First posted: 2018-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of participants completing the eight-day protocol using Soberlink Device
timeFrame: Baseline to end of study (eight days).
Secondary outcomes:
measure: Missed Soberlink test
timeFrame: Baseline to end of study (eight days)
measure: Positive BAC test received from Soberlink
timeFrame: Baseline to end of study (eight days)
measure: Scheduled Blood pressure and heart rate test is missed or out of range
timeFrame: Baseline to end of study (eight days)
measure: Subject's self-report on effect of breathalyzer device on their behavior
timeFrame: Baseline to end of study (eight days)
measure: Adverse events
timeFrame: Baseline to end of study (eight days)
measure: Subject not agreeable to clinical recommendations
timeFrame: Baseline to end of study (eight days)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Addiction Medicine and Dual Diagnosis Clinic
state: California
Study officials:
affiliation: Stanford University
name: Amer Raheemullah, MD
role: PRINCIPAL_INVESTIGATOR
References: