What this study is
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.
What's being tested
- Varenicline (VAR)
Intervention · 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 details
- Official title
- Varenicline for Smoking Cessation in Pancreatitis: An Open-Label Trial
- Sponsor
- Mayo Clinic
- Conditions
- Pancreatitis · Chronic Pancreatitis · Acute Pancreatitis (AP) · Recurrent Acute Pancreatitis
- Enrolling
- 45 people
- Starts
- 2026-11-13
- Est. completion
- 2029-11-01
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic
Rochester, Minnesota, United States
- Luis Ospina Velasquez · Contact507-538-1827OspinaVelasquez.Luis@mayo.edu
- Samuel Han · Principal investigator
Study team
Sponsor
Mayo Clinic
Study ID 26-007960
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.