Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis
NCT07171112 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-11-10
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.
Conditions
- Pancreatitis, Chronic
- Pancreatitis, Acute
- Recurrent Acute Pancreatitis
- Smoking (Tobacco) Addiction
Interventions
- DRUG
-
Increased Varenicline Dosing (1mg TID)
Varenicline 1mg PO (oral) three times daily
- DRUG
-
Standard Varenicline Dosing (1 mg BID)
Varenicline PO (oral) 1mg twice daily
- DRUG
-
Bupropion 150 mg twice daily
Bupropion 150 mg PO twice daily
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Samuel Han, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-06
- Primary Completion
- 2027-10-01
- Completion
- 2028-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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