Varenicline for Smoking Cessation in Pancreatitis

LO
SH
Overseen BySamuel Han
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests varenicline, a medication to help people stop smoking, in patients with pancreatitis. The goal is to determine its safety and effectiveness for these individuals to quit smoking after 12 weeks of use. People diagnosed with any form of pancreatitis who smoke at least five cigarettes a day may be suitable candidates if they wish to quit smoking soon. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

What is the safety track record for varenicline?

Research has shown that varenicline is generally safe for helping people quit smoking. In one study, only 0.6% of participants taking varenicline experienced serious side effects, compared to 1.4% of those taking a placebo, indicating that serious problems are rare. Another study found that varenicline did not increase serious health risks for people with heart disease. While some risks exist, most people tolerate it well. The FDA has approved varenicline for quitting smoking, confirming its safety.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard smoking cessation treatments like nicotine replacement therapies or buproprion, varenicline offers a unique approach by specifically targeting nicotine receptors in the brain. This reduces the pleasure derived from smoking and eases withdrawal symptoms, making it a powerful tool for those trying to quit smoking. Researchers are particularly excited about using varenicline in patients with pancreatitis, as smoking cessation can potentially alleviate symptoms and improve outcomes for these patients.

What is the effectiveness track record for varenicline in helping patients with pancreatitis stop smoking?

Research has shown that varenicline, the treatment tested in this trial, effectively helps people quit smoking. In one study, 44% of people using varenicline remained smoke-free for 12 weeks. Another study found that 77% of participants quit smoking between weeks 9 and 12. Varenicline reduces the urge to smoke by lessening cravings for nicotine, the addictive substance in cigarettes. It has increased the chances of quitting for up to a year. Overall, varenicline is a proven option for those looking to stop smoking.12678

Are You a Good Fit for This Trial?

This trial is for people diagnosed with any type of pancreatitis who currently smoke cigarettes and want to quit. Participants must be willing to take medication for 12 weeks and follow study instructions.

Inclusion Criteria

I want to quit smoking within the next 30 days.
I am 18 years old or older.
I have been diagnosed with acute or chronic pancreatitis.
See 5 more

Exclusion Criteria

Known hypersensitivity to varenicline
I have a seizure disorder or another condition that makes varenicline unsafe for me.
Current untreated psychotic disorder or acute manic episode that would interfere with participation or safe medication use
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varenicline for smoking cessation over a 12-week period

12 weeks
Regular visits for dosing adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Assessments and carbon monoxide measurements

What Are the Treatments Tested in This Trial?

Interventions

  • Varenicline

Trial Overview

The study tests varenicline, a prescription medicine used to help people stop smoking. All participants will receive varenicline treatment for 12 weeks, and researchers will check how many successfully quit smoking.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Varenicline treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Varenicline for smoking cessation: a narrative review of ... - PMC

The primary outcome was 4 weeks continuous abstinence at 12 weeks. Both studies had similarly significant results with 44% abstinence in the varenicline group ...

Cue restricted smoking increases quit rates with varenicline

Outcome data. At 12 weeks, 77% (217/281) of smokers in the CRS group reached the primary outcome between 9–12 weeks, confirmed through CO ...

Varenicline for Smoking Cessation in Pancreatitis

This study will look at how safe and how effective varenicline, a commonly used medication for smoking cessation, is in helping patients with ...

Comparative assessment of outcomes of smoking ...

Of the patient, 436 used medications, including varenicline, bupropion, and nicotine replacement therapy (NRT). The overall quit rate was 31.8% by the primary ...

First study in the world to evaluate efficacy and safety of the ...

Varenicline and psychological support can minimize the risk od diabetes and lead to higher chances of cessation. Besides, the most common side ...

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 ...

Smoking Cessation Medications for Pancreatitis

Specifically, just 0.6% of those taking varenicline had severe issues, compared to 1.4% in a placebo group.

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 ...