RecruitingPhase 2NCT07171112

Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis

Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis

Sponsor

Mayo Clinic

Enrollment

45 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Smoking (Tobacco) Addiction Pancreatitis, Chronic Recurrent Acute Pancreatitis Pancreatitis, Acute

Summary

The purpose of this research is to assess the effectiveness of two treatment strategies for smoking cessation in patients with acute recurrent pancreatitis or chronic pancreatitis who smoke cigarettes. All participants will receive varenicline, a commonly used medication that helps people stop smoking, at its standard dose. For those who are unable to stop smoking after 6 weeks of treatment, they will be randomly selected to either 1) increase their dose of varenicline, 2) combine varenicline with bupropion (another medication that helps with smoking cessation) or continue on the standard dose of varenicline. At the end of 12 weeks of treatment, participants will be asked if they have stopped smoking with confirmation done by measuring carbon monoxide levels in their breath.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

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:
amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
characteristic cross-sectional imaging
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 Criteria22

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.