- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582150
Ambulatory Alcohol Detoxification With Remote Monitoring
December 13, 2022 updated by: Anna Lembke, Stanford University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305-5723
- Stanford Addiction Medicine and Dual Diagnosis Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Receiving Soberlink Device
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants completing the eight-day protocol using Soberlink Device
Time Frame: Baseline to end of study (eight days).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Missed Soberlink test
Time Frame: Baseline to end of study (eight days)
|
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.
|
Baseline to end of study (eight days)
|
Positive BAC test received from Soberlink
Time Frame: Baseline to end of study (eight days)
|
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.
|
Baseline to end of study (eight days)
|
Scheduled Blood pressure and heart rate test is missed or out of range
Time Frame: Baseline to end of study (eight days)
|
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.
|
Baseline to end of study (eight days)
|
Subject's self-report on effect of breathalyzer device on their behavior
Time Frame: Baseline to end of study (eight days)
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Subjects will fill out surveys on the effect of using the device on their cravings and relapse.
|
Baseline to end of study (eight days)
|
Adverse events
Time Frame: Baseline to end of study (eight days)
|
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.
|
Baseline to end of study (eight days)
|
Subject not agreeable to clinical recommendations
Time Frame: Baseline to end of study (eight days)
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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.
|
Baseline to end of study (eight days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amer Raheemullah, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 3, 2018
Primary Completion (ANTICIPATED)
March 1, 2021
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
June 27, 2018
First Submitted That Met QC Criteria
June 27, 2018
First Posted (ACTUAL)
July 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 16, 2022
Last Update Submitted That Met QC Criteria
December 13, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-44681
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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