Continuous Alcohol Monitoring for Pancreatitis
Continuous Alcohol Monitoring for Pancreatitis
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.
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 NIAAA's 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 0.08%. 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.
Inclusion Criteria:

 -  Aged 18-75 years at the time of eligibility assessment

 -  History of at least one AP per Revised Atlanta Classification (20) within past 3 years
 from screening, which requires two of the following evidence of pancreatitis:

 -  Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric
 pain often radiating to the back)

 -  Serum lipase activity (or amylase activity) at least three times greater than the
 upper limit of normal

 -  Characteristic findings of AP on contrast-enhanced computed tomography (CECT),
 magnetic resonance imaging (MRI) or transabdominal ultrasonography

 -  Access to a mobile or portable device that has the capability to sync to the BACtrack
 sensor and internet connection for syncing purposes.

 Exclusion Criteria:

 -  Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune
 pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected
 cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.

 -  Episode of acute pancreatitis requiring hospitalization in the past 4 weeks.

 -  Current medical or psychiatric illnesses that in the investigator's opinion would
 compromise their ability to tolerate study procedures.

 -  Currently incarcerated.

 -  Known pregnancy.