Can a double-dose of quit-smoking meds help pancreatitis patients kick the habit?
NCT ID NCT07171112
First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times
Summary
This study tests whether increasing the dose of varenicline or adding bupropion helps people with recurrent acute or chronic pancreatitis quit smoking. All 45 participants start with standard varenicline; those still smoking after 6 weeks are randomly assigned to a higher dose, a combination, or continued standard dose. Success is measured by self-report and breath carbon monoxide levels at 12 and 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Varenicline and bupropion
- What this could lead to
- If successful, this could provide a tailored smoking cessation strategy for people with pancreatitis, potentially reducing disease flares and complications.
- What could go wrong
- This is a small Phase 2 trial with only 45 participants, so results may not apply broadly. The higher drug doses may cause more side effects, and quitting smoking is difficult even with medication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
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Nov 2025
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 recurrent acute pancreatitis or chronic pancreatitis as defined by the American Pancreatic Association: o Chronic Pancreatitis (any of the following): i. Moderate/marked pancreas imaging morphology (i.e. ductal and parenchymal abnormalities ii. Pancreatic calcifications iii. Histologic confirmation o Recurrent Acute Pancreatitis: i. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, defined by at least 2 of the following 3: 1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values 2. characteristic cross-sectional imaging 3. typically upper abdominal pain according to the revised Atlanta classification * Currently smoking ≥ 5 cigarettes/day * 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 * Ongoing acute pancreatitis or prior episode of pancreatitis in previous 30 days * No desire to quit smoking * Currently undergoing smoking cessation intervention (i.e. nicotine replacement therapy, varenicline, counseling, bupropion). * Known allergic reactions to varenicline or bupropion SR * History of seizures * History of an eating disorder (anorexia or bulimia) * Closed head trauma with any loss of consciousness or amnesia in the last 5 year * Ever history of closed head trauma with \> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion * Ever history of alcohol withdrawal * Ever history of chronic kidney disease (creatine clearance \< 30 mL/minute) * Liver impairment (i.e. history of cirrhosis) with aminotransferase elevation ≥ 2 times the upper limit of normal and/or alkaline phosphatase elevation ≥ 2 times the upper limit of normal. * History of bipolar disorder or psychosis * Ongoing or recent use (prior 14 days) of any monoamine oxidase inhibitors (isocarboxazid, phenelzine, tranylcypromine, selegiline). * Regular use of potent CYP2B6 inhibitors (i.e. clopidogrel, ticlopidine) * Regular use of CYP2D6 substrates with narrow therapeutic indices (e.g. flecainide, propafenone, tricyclic antidepressants such as nortriptyline, thioridazine, vinblastine) * History of acute angle closure glaucoma * Meet criteria for depression as assessed by the Center for Epidemiologic Studies - Depression (CES-D) with a score of 16 or higher. * Psychiatric hospitalization within 1 year of screening * Participants who have a score of 3 or higher on the Columbus-Suicide Severity Rating Scale (C-SSRS) at enrollment or during any of the study assessments will be excluded * Unable to provide consent for self Incarcerated * Pregnant females. All female patients of childbearing potential must have a negative pregnancy test and must agree to use highly effective (failure rate \<1%) contraception during participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Rochester, Minnesota, 55902, United States
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