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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Shelly Ward
Ward.Shelly1@mayo.edu
507-538-9997
Time Frame
Start Date: 2025-11-06
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 45
Treatments
Active_comparator: Continuation of standard varenicline dosing (1mg BID)
1\. A group that continues to take varenicline 1mg twice a day (no change)
Experimental: Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID
A group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID)
Experimental: Increased Varenicline Dosing (1 mg TID)
A group assigned to increased varenicline (1mg oral three times a day) dosing
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov