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| Name | Class |
|---|---|
| SoberLink, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving Soberlink Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Monitoring with Ambulatory Detox | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of study (eight days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amer Raheemullah, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Addiction Medicine and Dual Diagnosis Clinic | Stanford | California | 94305-5723 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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. | 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. | 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. | 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. | 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. | Baseline to end of study (eight days) |