PancreatitisPhase 4NCT07874841
Varenicline for Smoking Cessation in Pancreatitis
A Phase 4 study testing Varenicline (VAR) in people with Pancreatitis and Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Chronic Pancreatitis, Acute Pancreatitis (AP)
- What is being tested?
- Varenicline (VAR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2026to 1 Nov 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Rochester, Minnesota, 55905
Luis Ospina Velasquez, 507-538-1827, OspinaVelasquez.Luis@mayo.edu
Samuel Han
About this study
Official title: Varenicline for Smoking Cessation in Pancreatitis: An Open-Label Trial
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.
Read the 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.
- Being tested
- Varenicline (VAR)
- Keywords
- pancreatitis, chronic pancreatitis, acute pancreatitis, recurrent acute pancreatitis, smoking cessation, varenicline
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Varenicline treatment | Experimental | 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 Receives: Drug: Varenicline (VAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start13 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Han, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874841
- Sponsor's protocol ID
- 26-007960
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and de-identified study results will be shared upon approval of a formal analysis plan reviewed by the study investigators.
Publications
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 41544102Han 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 27101574