Alcohol Use DisorderNCT03582150
Ambulatory Alcohol Detoxification With Remote Monitoring
A study testing Remote Monitoring with Ambulatory Detox in people with Alcohol Use Disorder, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Remote Monitoring with Ambulatory Detox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Addiction Medicine and Dual Diagnosis Clinic
Stanford, California, 94305-5723
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Remote Monitoring with Ambulatory Detox
- Keywords
- Ambulatory alcohol detoxification, alcohol withdrawal, remote monitoring with breathalyzer
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring with Ambulatory DetoxDevice
- 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 group | Role | What they receive |
|---|---|---|
| Receiving Soberlink Device | Experimental | Not described Receives: Device: Remote Monitoring with Ambulatory Detox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of study (eight days).
Secondary outcomes (6)
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.
Measured: Baseline to end of study (eight days)
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.
Measured: Baseline to end of study (eight days)
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.
Measured: Baseline to end of study (eight days)
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.
Measured: Baseline to end of study (eight days)
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.
Measured: Baseline to end of study (eight days)
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.
Measured: Baseline to end of study (eight days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start3 Jul 2018
- Primary completionMar 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Funding lost during COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- SoberLink, LLC
- Responsible party
- Principal investigator, Anna Lembke, Stanford University
- Investigators
- Amer Raheemullah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582150
- Sponsor's protocol ID
- IRB-44681
- Status last verified
- Dec 2022
- First submitted
- 27 Jun 2018
- Last updated
- 16 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Alcohol Detoxification With Remote Monitoring
- ClinicalTrials.gov ID
- NCT03582150
- Acronym / sponsor ID
- IRB-44681
- Conditions
- Alcohol Use Disorder
- Keywords
- Ambulatory alcohol detoxification, alcohol withdrawal, remote monitoring with breathalyzer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding lost during COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- SoberLink, LLC
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving Soberlink Device | Experimental | Device: Remote Monitoring with Ambulatory Detox |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Receiving Soberlink Device |
Primary outcome
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.
6 secondary outcomes
Missed Soberlink test
Time frame: Baseline to end of study (eight days)
Positive BAC test received from Soberlink
Time frame: 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)
Subject's self-report on effect of breathalyzer device on their behavior
Time frame: Baseline to end of study (eight days)
Adverse events
Time frame: Baseline to end of study (eight days)
Subject not agreeable to clinical recommendations
Time frame: Baseline to end of study (eight days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amer Raheemullah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring with Ambulatory Detox in people with Alcohol Use Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing the eight-day protocol using Soberlink Device (time frame: Baseline to end of study (eight days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.