Continuous Alcohol Monitoring for Pancreatitis

Alcohol Drinking Clinical Trial

— CAMP  

Official title:

Application of a Wearable Alcohol Sensor for Prevention of Pancreatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04350996
• Other study ID #: STUDY00000526
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: June 2021

Study information

• Verified date: April 2020
• Source: Cedars-Sinai Medical Center
• Contact: Gillian Gresham Gresham, PhD
• Phone: 410-323-3341
• Email: gillian.gresham[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Pancreatitis

Intervention

Other:
• Wearable alcohol sensor
BACtrack Skyn, is a novel transdermal blood alcohol sensor developed by BACtrack, a company established for police-grade breathalyzers, and winner of the Wearable Alcohol Biosensor Challenge sponsored National Institute on Alcohol Abuse and Alcoholism.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period	Feasibility based on proportion of patients who wore the BACTrack sensor for at least 50% of study duration	up to 14 days
Secondary	Acceptability of the BACtrack Skyn using the System Usability Scale (SUS)	SUS is a 10 item questionnaire, with 5 Likert-type response options (range 1(strongly disagree) to 5 (strongly agree)). Sensors will be deemed acceptable if =75% of the study population report an acceptability score of 68 or greater	14 days
Secondary	Blood alcohol concentration (BACtrack breathalyzer)	Daily levels of estimated BAC using breathalyzer (continuous)	up to 14 days
Secondary	Patient-reported alcohol consumption	Number of alcoholic beverages each day	up to 14 days
Secondary	Urine alcohol consumption	Urine alcohol metabolite (ethyl glucuronide [EtG]) levels (continuous)	14 days
Secondary	Patient-reported pain	Daily visual analog scale (range 0(low)-10 (high))	up to 14 days