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Recruiting Phase 2 NCT07171112

Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis

Trial Parameters

Condition Pancreatitis, Chronic
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 45
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-06
Completion 2027-10-01
Interventions
Standard Varenicline Dosing (1 mg BID)Bupropion 150 mg twice dailyIncreased Varenicline Dosing (1mg TID)

Brief Summary

The purpose of this research is to assess the effectiveness of two treatment strategies for smoking cessation in patients with acute recurrent pancreatitis or chronic pancreatitis who smoke cigarettes. All participants will receive varenicline, a commonly used medication that helps people stop smoking, at its standard dose. For those who are unable to stop smoking after 6 weeks of treatment, they will be randomly selected to either 1) increase their dose of varenicline, 2) combine varenicline with bupropion (another medication that helps with smoking cessation) or continue on the standard dose of varenicline. At the end of 12 weeks of treatment, participants will be asked if they have stopped smoking with confirmation done by measuring carbon monoxide levels in their breath.

Eligibility Criteria

Inclusion Criteria * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 or older * Diagnosed with either recurrent acute pancreatitis or chronic pancreatitis as defined by the American Pancreatic Association: o Chronic Pancreatitis (any of the following): i. Moderate/marked pancreas imaging morphology (i.e. ductal and parenchymal abnormalities ii. Pancreatic calcifications iii. Histologic confirmation o Recurrent Acute Pancreatitis: i. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, defined by at least 2 of the following 3: 1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values 2. characteristic cross-sectional imaging 3. typically upper abdominal pain according to the revised Atlanta classification * Currently smoking ≥ 5 cigarettes/day * Explicitly express a desire

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