Mayo Clinic
Not reportedRochester, Minnesota, 55905, United States
Site contacts (2)
Samuel HanPrincipal investigator
CLINICAL STUDY · NCT07874841
Varenicline for Smoking Cessation in Pancreatitis
Not yet recruitingPhase 4Interventional
Sponsored by Mayo Clinic
- Condition
- Pancreatitis, Chronic Pancreatitis, Acute Pancreatitis (AP), Recurrent Acute Pancreatitis
- Study locations
- 1 reported site
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
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.
Full official title
Varenicline for Smoking Cessation in Pancreatitis: An Open-Label Trial
Detailed description
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.
PARTICIPATION
Who may participate
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion 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 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.
* 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.
NEAR YOU
Study locations worldwide
1 siteCheck the individual site’s status and contact the listed study team for current availability.
1 site shown
No centres match this search. Try another hospital, city, state or country.
WHAT IS BEING STUDIED
Treatments and study groups
Interventions
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
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
Study groups: Varenicline treatment
Study groups
Varenicline treatment
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
* 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
Interventions: Drug: Varenicline (VAR)
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Study model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants · Estimated
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 13 Nov 2026 · Estimated
- Primary completion
- 1 Nov 2028 · Estimated
- Study completion
- 1 Nov 2029 · Estimated
- First registered
- 15 Oct 2026 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (1)
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.
Secondary outcomes (3)
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
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- Mayo Clinic
- Sponsor type
- Other
- Collaborators
- Not reported
- Organisation study ID
- 26-007960
Central study contacts
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.
Publications (2)
- 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. PubMed ↗
- 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. PubMed ↗