A Phase 4 interventional study of Varenicline (VAR) in Pancreatitis, Chronic Pancreatitis and Acute Pancreatitis (AP), sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
This study will look at how safe and how effective varenicline, a commonly used medication for smoking cessation, is in helping patients with pancreatitis stop smoking cigarettes. Individuals who agree to be part of the study will be treated with varenicline for 12 weeks, after which the investigators will see how many have stopped smoking.
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.
759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's planned enrollment of 45 is below the median of 80 across 450 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Exclusion Criteria:
All participants in this arm will receive standard dosing of oral varenicline for 12 weeks. Dosing entails the following: * 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
Drug: Varenicline (VAR)
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
Rate of Smoking Cessation
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.
Time frame: 12-weeks.
Reduction in smoking
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.
Time frame: 12 weeks.
Retention proportion
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.
Time frame: 24 weeks.
Treatment acceptability
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.
Time frame: 12 weeks
Plan to share: Yes — Study protocol and de-identified study results will be shared upon approval of a formal analysis plan reviewed by the study investigators.
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD and supporting information will be made available after publication of the primary study results for a total duration of 4 years.
Access criteria: Investigators who submit a formal request for data that is approved by study investigators will be able to access de-identified IPD.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Varenicline