Smoking Cessation Medications for Pancreatitis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Varenicline

Must not be taking: Nicotine replacement, MAO inhibitors

Disqualifiers: Seizures, Eating disorders, Alcohol withdrawal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively different treatments help people with pancreatitis quit smoking. All participants will initially receive a standard dose of varenicline, a medication that aids in smoking cessation. If someone continues smoking after six weeks, they will either maintain the standard dose, increase the dose, or add another medication called bupropion. The trial seeks individuals diagnosed with either recurrent acute pancreatitis or chronic pancreatitis, who smoke at least five cigarettes a day, and wish to quit within the next 30 days. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using smoking cessation treatments like nicotine replacement therapy, varenicline, or bupropion. Also, certain medications like monoamine oxidase inhibitors and some antidepressants are not allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that varenicline is generally well-tolerated by people trying to quit smoking. One study found that only a small number of participants experienced serious side effects. Specifically, just 0.6% of those taking varenicline had severe issues, compared to 1.4% in a placebo group. This suggests that varenicline is as safe as, or even safer than, not taking it at all.

When combined with bupropion, another smoking cessation aid, most people experienced only mild side effects without serious problems. This combination has been tested and found to be relatively safe.

Overall, both varenicline alone and with bupropion have helped people quit smoking with few serious side effects. Participants in studies handled these medications well, making them a promising option for those wanting to stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pancreatitis because they explore different ways to enhance smoking cessation efforts, which can be crucial for managing this condition. Varenicline, known for its role in reducing nicotine cravings, is being tested in standard doses, increased doses, and in combination with bupropion, an antidepressant that may further aid in quitting smoking. The combination therapy could potentially offer a more effective approach by addressing both the chemical and behavioral aspects of addiction. Meanwhile, the increased varenicline dosing might provide enhanced efficacy for those who need a stronger intervention. These approaches aim to improve smoking cessation outcomes, ultimately benefiting patients with pancreatitis by reducing inflammation and promoting healing.

What evidence suggests that this trial's treatments could be effective for smoking cessation in pancreatitis patients?

Research has shown that varenicline helps people quit smoking, even those with challenging conditions like heart disease. This medication blocks nicotine's effects in the brain, reducing cravings and withdrawal symptoms. In this trial, one group will continue with standard varenicline dosing, while another group will receive increased dosing. Additionally, a separate group will receive a combination of varenicline with bupropion. Studies have found that combining varenicline with bupropion, another smoking cessation aid, is even more effective, especially for those who struggle to quit. This combination is linked to higher success rates in staying smoke-free long-term. Both methods offer promising help for smokers, including those with pancreatitis who want to quit. ^{1 2 3 6 7}

Who Is on the Research Team?

Samuel Han, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with recurrent acute pancreatitis or chronic pancreatitis who currently smoke cigarettes. Participants must be willing to take medication to help quit smoking and will have their progress monitored over a 12-week period.

Inclusion Criteria

Provision of signed and dated informed consent form

Currently smoking ≥ 5 cigarettes/day

Willing and able to comply with trial protocol and follow-up

Exclusion Criteria

No desire to quit smoking

Known allergic reactions to varenicline or bupropion SR

History of an eating disorder (anorexia or bulimia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard varenicline dosing for smoking cessation for 6 weeks. Non-abstainers are then randomized to different treatment options for an additional 6 weeks.

12 weeks

Regular visits for assessments and carbon monoxide level measurements

Follow-up

Participants are monitored for smoking cessation and other outcomes 24 weeks after treatment initiation

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupropion
• Varenicline

Trial Overview The study tests the effectiveness of varenicline, a smoking cessation drug, at standard doses. If unsuccessful after 6 weeks, participants may receive an increased dose or combine it with bupropion. Smoking status is confirmed by measuring breath carbon monoxide levels.

How Is the Trial Designed?

Group I: Increased Varenicline Dosing (1 mg TID) Experimental Treatment 1 Intervention

A group assigned to increased varenicline (1mg oral three times a day) dosing

Group II: Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID Experimental Treatment 2 Interventions

A group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID)

Group III: Continuation of standard varenicline dosing (1mg BID) Active Control 1 Intervention

1\. A group that continues to take varenicline 1mg twice a day (no change)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5021547/

Smoking Cessation in a Chronic Pancreatitis Population Smoking cessation in the chronic pancreatitis population is extremely challenging, as shown by our 0% quit rate after 18 months. Given that smokers with chronic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07171112

Smoking Cessation Trial in Recurrent Acute Pancreatitis ... This randomized trial evaluates the safety and efficacy of varenicline-based smoking cessation treatment for patients with recurrent acute pancreatitis and ...

3. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.109.869008

Efficacy and Safety of Varenicline for Smoking Cessation in ... Conclusions— Varenicline is effective for smoking cessation in smokers with cardiovascular disease. It was well tolerated and did not increase ...

4. journals.lww.com journals.lww.com/ajg/fulltext/2025/10002/s230_smoking_cessation_in_chronic_pancreatitis_.230.aspx

S230 Smoking Cessation in Chronic Pancreatitis Our objective for this study was to evaluate the prevalence of active smoking and utilization of evidence-based smoking cessation interventions among patients ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/17474124.2023.2190513

Breaking through the smoking barrier in pancreatitis Meta-analyses have demonstrated overall smoking cessation rates of 8.5% with counseling, 16.3% with nicotine replacement therapy (NRT), and 18% with bupropion ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6936106/

A Randomized Controlled Trial of 24-Weeks of Varenicline for ... A pilot study and an initial report describing 12-week open-label outcomes from this trial indicated that varenicline might be safe and efficacious for cancer ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1812963

Maintenance Treatment With Varenicline for Smoking ... In a recent trial, 12 weeks of maintenance treatment with varenicline improved abstinence rates at 1 year in smokers without psychiatric illness ...