Ambulatory Alcohol Detoxification With Remote Monitoring

NCT03582150 | Withdrawn FDA Device

• 1 other identifier: IRB-44681
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Ambulatory alcohol detoxification; alcohol withdrawal; remote monitoring with breathalyzer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to end of study (eight days).

Secondary Outcomes (6)

• Missed Soberlink test

  Baseline to end of study (eight days)

• Positive BAC test received from Soberlink

  Baseline to end of study (eight days)

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

  Baseline to end of study (eight days)

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

  Baseline to end of study (eight days)

• Adverse events

  Baseline to end of study (eight days)

Study Arms (1)

Receiving Soberlink Device

EXPERIMENTAL

Device: Remote Monitoring with Ambulatory Detox

Interventions

Remote Monitoring with Ambulatory Detox 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.

Receiving Soberlink Device

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• SoberLink, LLC: collaborator

Study Sites (1)

Stanford Addiction Medicine and Dual Diagnosis Clinic

Stanford, California, 94305-5723, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amer Raheemullah, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 10, 2018
• Study Start: July 3, 2018
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)