Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04350996
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2020-04-15
Brief Title:
Continuous Alcohol Monitoring for Pancreatitis
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Application of a Wearable Alcohol Sensor for Prevention of Pancreatitis
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP
Brief Summary:
The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device BACtrack Skyn and to correlate biological and self-reported alcohol measures with the transdermal alcohol measures in patients with a history of pancreatitis The results from this study will inform tailored self-directed interventions for reducing alcohol consumption in persons with pancreatitis
Detailed Description:
Alcohol is the leading cause of recurrent acute and chronic pancreatitis which greatly elevates the risk of pancreatic cancer Reducing alcohol intake in patients with a history of alcoholic pancreatitis prevents progression of pancreatitis Provider-based education on alcohol reduction has not translated to sustainable behaviors change and more effective and scalable interventions are needed Wearable alcohol sensors can empower patient-directed behavior change through real-time feedback on alcohol levels in the blood BACtrack Skyn the winner of NIAAAs Wearable Alcohol Biosensor Challenge is a validated transdermal alcohol sensor that estimates blood alcohol concentration In this pilot study the investigators aim to a determine the feasibility and acceptability of using BACtrack Skyn to monitor changes in blood alcohol concentration among patients at risk for pancreatitis b assess correlations between alcohol levels measured with BACtrack Skyn breathalyzer patient-reported alcohol consumption and urine alcohol metabolite levels c explore whether the use of a wearable alcohol sensor results in a decrease in alcohol consumption over a two-week period Sixteen participants with known history of alcoholic pancreatitis will be assigned to wearing BACtrack Skyn for 2 weeks with the goal of not exceeding a blood alcohol concentration of 008 Patient-reported drinking history urine will be collected to correlate reported drinking levels and alcohol metabolic levels with the blood alcohol concentration readings in BACtrack Skyn Findings from this study will be used as preliminary data to support and optimize subsequent grant applications and inform larger randomized trials The proposed study aligns closely with the mission of Cedars-Sinai and contributes to the growing body of research focusing on novel technologies for cancer prevention and control as well as translational studies on alcoholic gastrointestinal diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None