Actively Recruiting
Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis
Led by Mayo Clinic · Updated on 2025-11-10
45
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the entire study
- Male or female, aged 18 years or older
- Diagnosed with recurrent acute pancreatitis or chronic pancreatitis as defined by the American Pancreatic Association
- Currently smoking 5 or more cigarettes per day
- Express a desire to quit smoking within 30 days
- Able to take oral medications and willing to follow the study treatment plan
- Willing and able to comply with the study protocol and follow-up visits
You will not qualify if you...
- Under 18 years of age
- Acute pancreatitis episode ongoing or within the last 30 days
- No desire to quit smoking
- Currently undergoing any smoking cessation treatment (nicotine replacement, varenicline, counseling, bupropion)
- Known allergy to varenicline or bupropion sustained release
- History of seizures
- History of eating disorders such as anorexia or bulimia
- Head injury with loss of consciousness or amnesia in the past 5 years
- History of severe head trauma with prolonged unconsciousness or brain injury
- History of alcohol withdrawal
- Chronic kidney disease with creatinine clearance less than 30 mL/min
- Liver impairment with significant enzyme elevation
- History of bipolar disorder or psychosis
- Use of monoamine oxidase inhibitors within the past 14 days
- Regular use of certain medications including potent CYP2B6 inhibitors or CYP2D6 substrates with narrow therapeutic windows
- History of acute angle closure glaucoma
- Depression with CES-D score 16 or higher
- Psychiatric hospitalization within 1 year
- Suicide risk score of 3 or higher on the C-SSRS
- Unable to provide consent
- Incarcerated individuals
- Pregnant women or women not agreeing to use highly effective contraception during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
Research Team
S
Shelly Ward
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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