Varenicline for Smoking Cessation in Pancreatitis

This prospective single-center open-label trial will examine the safety, feasibility and efficacy of a 12-week treatment course of varenicline in helping patients with pancreatitis stop smoking cigarettes.

• Varenicline (VAR) (Drug): Varenicline is the treatment being offered in this treatment. Treatment will entail oral varenicline 1 mg twice a day (BID) for a total of 12 weeks. Initial titration begins in the following manner: * Days 1-3: 0.5 mg once daily * Days 4-7: 0.5 mg twice daily * Day 8 through end of treatment (12 weeks): 1 mg twice daily

Primary outcomes

• Rate of Smoking Cessation [12-weeks.]: The primary outcome, smoking cessation, is defined as quitting smoking cigarettes completely by the end of the 12-week treatment period. This will be confirmed via exhaled carbon monoxide measurement. The rate of smoking cessation will be calculated as the proportion of participants who quit smoking over the 12-week treatment period.

Secondary outcomes

• Reduction in smoking [12 weeks.]: Reduction in smoking will be defined as any decrease in the number of the cigarettes smoked a day from baseline to 12 weeks of treatment.
• Retention proportion [24 weeks.]: Retention is described as the proportion of enrolled participants who remain in the study until the end of the study period, having completed all assessments and carbon monoxide measurements.
• Treatment acceptability [12 weeks]: The acceptability of the treatment, oral varenicline, from the participant's perspective will be measured using the Treatment Evaluation Inventory Short Form (score range 9-45, higher scores representing greater acceptance of a given treatment). Scores > 27 will indicate at least moderate treatment acceptability.

Sex: All, ages: 18 Years to any

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 acute pancreatitis, recurrent acute pancreatitis or chronic pancreatitis as defined by the American Pancreatic Association.
* Currently smoking cigarettes daily or on most days, with an average of ≥5 cigarettes/day over the past 30 days.
* Explicitly express a desire to quit within 30 days
* Ability to take oral medication and be willing to adhere to the study intervention regimen
* Willing and able to comply with trial protocol and follow-up

Exclusion Criteria:

* Age < 18 years of age.
* No desire to quit smoking within 30 days.
* Known hypersensitivity to varenicline
* Active seizure disorder or other medical condition judged by the investigator to make varenicline unsafe.
* History of chronic kidney disease (creatinine clearance < 30 mL/minute)
* Current untreated psychotic disorder or acute manic episode that would interfere with participation or safe medication use.
* Unable to provide informed consent.

• Han S, Yadav D, Xu J, Bellin MD, Fisher WE, Fogel EL, Forsmark C, Hart PA, Li L, Pandol SJ, Park WG, Trikudanathan G, Van Den Eeden SK, Vege SS, Conwell DL, Jeon CY; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Comprehensive Assessment of Direct and Passive Smoking Across the Pancreatitis Spectrum. Pancreas. 2026 Jul 1;55(6):e653-e660. doi: 10.1097/MPA.0000000000002621. PMID 41544102
• Han S, Kheder J, Bocelli L, Fahed J, Wachholtz A, Seward G, Wassef W. Smoking Cessation in a Chronic Pancreatitis Population. Pancreas. 2016 Oct;45(9):1303-8. doi: 10.1097/MPA.0000000000000641. PMID 27101574