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Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis
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.
This randomized trial evaluates the safety and efficacy of varenicline-based smoking cessation treatment for patients with recurrent acute pancreatitis and chronic pancreatitis. Participants who currently smoke cigarettes and have a desire to quit smoking will be eligible to participate in this study. Upon providing informed consent, baseline information regarding quality of life, pain, smoking history, and mental health will be collected for each participant in addition to an exhaled carbon monoxide level measurement. Participants will then be started on standard varenicline dosing for smoking cessation (1mg PO BID) for 6 weeks. Participants who continue to smoke (non-abstainers) after 6 weeks will then be randomized into 3 treatment options: 1\) Increased varenicline dosing (1mg PO TID) 2) Combination of varenicline (1mg PO BID) with bupropion (150mg PO BID) or 3) Continued standard dosing of varenicline (1 mg PO BID) for an additional 6 weeks. After 12 weeks of treatment, participants will be asked about their smoking status, have an exhaled carbon monoxide level measured and will repeat their assessments of quality of life, pain, mental health and smoking urges.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic
Rochester, Minnesota, United States
Start Date
November 6, 2025
Primary Completion Date
October 1, 2027
Completion Date
October 1, 2028
Last Updated
November 10, 2025
45
ESTIMATED participants
Standard Varenicline Dosing (1 mg BID)
DRUG
Bupropion 150 mg twice daily
DRUG
Increased Varenicline Dosing (1mg TID)
DRUG
Lead Sponsor
Mayo Clinic
NCT07406698
NCT07024199
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06549725