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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for Smoking Cessation in Pancreatitis: An Open-Label Trial
- ClinicalTrials.gov ID
- NCT07874841
- Acronym / sponsor ID
- 26-007960
- Keywords
- pancreatitis, chronic pancreatitis, acute pancreatitis, recurrent acute pancreatitis, smoking cessation, varenicline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varenicline treatment | Experimental | Drug: Varenicline (VAR)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Varenicline treatment |
Primary outcome
Rate of Smoking Cessation
Time frame: 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.
3 secondary outcomes
Reduction in smoking
Time frame: 12 weeks.
Retention proportion
Time frame: 24 weeks.
Treatment acceptability
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 41544102Han 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.
- Background: PubMed 27101574Han 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.
- Individual participant dataSharing planned: Yes. Study protocol and de-identified study results will be shared upon approval of a formal analysis plan reviewed by the study investigators.
Related trials for Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline (VAR) in people with Pancreatitis and Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Ospina Velasquez (507-293-5574, OspinaVelasquez.Luis@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Smoking Cessation (time frame: 12-weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07874841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.