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Ambulatory Alcohol Detoxification With Remote Monitoring

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ClinicalTrials.gov Identifier: NCT03582150
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
SoberLink, LLC
Information provided by (Responsible Party):
Anna Lembke, Stanford University

Tracking Information
First Submitted Date  ICMJE June 27, 2018
First Posted Date  ICMJE July 10, 2018
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE July 3, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
Completion of four days using Soberlink Device [ Time Frame: Baseline to end of study (four days). ]
The Subject will be enrolled on a Monday and return to the site for an evaluation by the study staff on Tuesday. If Subject complies with the guidelines of the study, the daily dose sedative will be provided. On or after the fourth day of the study, the Subject will return to the study site for a final evaluation outcomes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • 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.
  • 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.
  • 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.
  • Subject's self-report on effect of breathalyzer device on their behavior [ Time Frame: Baseline to end of study (eight days) ]
    Subjects will fill out surveys on the effect of using the device on their cravings and relapse.
  • 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.
  • Subject not agreeable to clinical recommendations [ Time Frame: Baseline to end of study (eight days) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
  • Missed Soberlink test [ Time Frame: Baseline to end of study (four 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.
  • Positive BAC test received from Soberlink [ Time Frame: Baseline to end of study (four 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.
  • Scheduled Blood pressure and heart rate test is missed or out of range [ Time Frame: Baseline to end of study (four 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.
  • Subject's self-report on effect of breathalyzer device on their behavior [ Time Frame: Baseline to end of study (four days) ]
    Subjects will fill out surveys on the effect of using the device on their cravings and relapse.
  • Adverse events [ Time Frame: Baseline to end of study (four 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.
  • Subject not agreeable to clinical recommendations [ Time Frame: Baseline to end of study (four days) ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambulatory Alcohol Detoxification With Remote Monitoring
Official Title  ICMJE Ambulatory Alcohol Detoxification With Remote Monitoring
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: Receiving Soberlink Device
Intervention: Device: Remote Monitoring with Ambulatory Detox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Amer Raheemullah, MD 650-498-9111 raheem@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582150
Other Study ID Numbers  ICMJE IRB-44681
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anna Lembke, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE SoberLink, LLC
Investigators  ICMJE
Principal Investigator: Amer Raheemullah, MD Stanford University
PRS Account Stanford University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP