Clinical trial NCT04350996: Continuous Alcohol Monitoring for Pancreatitis
Official title: Application of a Wearable Alcohol Sensor for Prevention of Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatitis
Alcohol Drinking
Keywords: Wearable technology
Remote monitoring
Pancreatitis
Continuous alcohol monitoring
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will have acute or chronic pancreatitis without calcification and have alcohol consumption score of ≥ 3 as measured using the validated TWEAK scale.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period
timeFrame: up to 14 days
Secondary outcomes:
measure: Acceptability of the BACtrack Skyn using the System Usability Scale (SUS)
timeFrame: 14 days
measure: Blood alcohol concentration (BACtrack breathalyzer)
timeFrame: up to 14 days
measure: Patient-reported alcohol consumption
timeFrame: up to 14 days
measure: Urine alcohol consumption
timeFrame: 14 days
measure: Patient-reported pain
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References: