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Ambulatory Alcohol Detoxification With Remote Monitoring

NCT03582150 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Amer Raheemullah, MD · Stanford University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2021-03-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582150 on ClinicalTrials.gov