Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis

Not Applicable

Not yet recruiting

• Conditions: Pancreatitis, Chronic; Pancreatitis, Acute; Recurrent Acute Pancreatitis; Smoking (Tobacco) Addiction
• Interventions: Drug: Standard Varenicline Dosing (1 mg BID); Drug: Increased Varenicline Dosing (1mg TID); Drug: Bupropion 150 mg twice daily

• Registration Number: NCT07171112
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Continuation of standard varenicline dosing (1mg BID)	Standard Varenicline Dosing (1 mg BID)	1\. A group that continues to take varenicline 1mg twice a day (no change)
Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID	Standard Varenicline Dosing (1 mg BID)	A group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID)
Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID	Bupropion 150 mg twice daily	A group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID)
Increased Varenicline Dosing (1 mg TID)	Increased Varenicline Dosing (1mg TID)	A group assigned to increased varenicline (1mg oral three times a day) dosing

Primary Outcome Measures

Name	Time	Method
Proportion of participants who quit smoking at 12 weeks of treatment	12 weeks	This outcome measures the number of participants who quit smoking (out of the total number of participants for that intervention arm) after 12 weeks of treatment. Smoking cessation is assessed using a questionnaire that directly asks participants if they have smoked any cigarettes in the last 7 days. Smoking cessation is then confirmed by measuring an exhaled carbon monoxide level using a carbon monoxide monitor.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who have quit smoking 24 weeks after treatment initiation	24 weeks	This outcome measures the number of participants who have quit smoking (out of the total number of participants for that intervention arm) 24 weeks after starting treatment. Smoking cessation is assessed using a questionnaire that directly asks participants if they have smoked any cigarettes in the last 7 days.
Reduction in Smoking	12 weeks and 24 weeks	Number of cigarettes smoked per day. This outcome measures whether there has been any change (decrease) in the number of cigarettes smoked a day.
Serious quit attempts	12 weeks	Number of attempts where smoking was stopped for at least 24 hours. This outcome measures the number of quitting attempts made by participants during the 12 weeks of treatment.
Treatment Engagement and Retention	12 weeks	What proportion of participants adhered to the study protocol and continued with the study until completion
Treatment Acceptability	12 weeks	This outcome measures whether the assigned treatment was acceptable to participants. This will be assessed using the Treatment Evaluation Inventory - Short Form (score range 9-45, with higher scores representing greater acceptance of the treatment). This questionnaire uses a 5-point scale and contains 9 questions. A total score of 27 or higher would demonstrate moderate treatment acceptability.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States