Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial.
Jon O Ebbert, Dorothy K Hatsukami, Ivana T Croghan...
https://pubmed.ncbi.nlm.nih.gov/24399554Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07171112
Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis
Led by Mayo Clinic · Updated on 2025-11-10
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different treatment strategies to help patients with recurrent acute pancreatitis or chronic pancreatitis who smoke cigarettes to quit smoking. This study focuses on assessing the safety and effectiveness of varenicline-based treatments, a medication commonly used to assist smoking cessation, given its importance for people suffering from these pancreatic conditions. Participants must currently smoke and wish to quit, highlighting the study's goal to support smoking cessation in this specific patient group. All participants will begin treatment with the standard dose of varenicline, taken orally twice daily for six weeks. Those who continue to smoke after this period will be randomly assigned to one of three groups: increasing the varenicline dose to three times daily, combining the standard varenicline dose with bupropion taken twice daily, or continuing the standard varenicline dose. The treatment phase lasts a total of 12 weeks with these dosing adjustments made after the first six weeks. During the study, participants will have their smoking status checked through self-report and a breath test measuring carbon monoxide levels. Additional assessments will include quality of life, pain, mental health, and urges to smoke. These evaluations occur at the start and end of the 12-week treatment, with follow-up measures at 24 weeks to monitor smoking cessation success, treatment engagement, and acceptability. The study is designed to carefully monitor participants throughout this period to understand the impact of the treatment strategies.
CONDITIONS
Brief Title
Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 years or older
- Diagnosed with recurrent acute pancreatitis or chronic pancreatitis as defined by accepted medical guidelines
- Currently smoking at least 5 cigarettes per day
- Desire to quit smoking within 30 days
- Able to take oral medication and willing to follow study treatment
- Willing and able to comply with the trial protocol and follow-up
You will not qualify if you...
- Under 18 years of age
- Acute pancreatitis ongoing or episode within the last 30 days
- No desire to quit smoking
- Currently using any smoking cessation treatment such as nicotine replacement, varenicline, counseling, or bupropion
- Known allergy to varenicline or bupropion SR
- History of seizures
- History of eating disorders like anorexia or bulimia
- Head trauma with loss of consciousness or amnesia in the past 5 years or severe head trauma history
- History of alcohol withdrawal
- Chronic kidney disease with creatinine clearance below 30 mL/min
- Liver impairment with certain enzyme elevations
- History of bipolar disorder or psychosis
- Use of monoamine oxidase inhibitors within 14 days
- Regular use of certain medications affecting metabolism
- History of acute angle closure glaucoma
- Depression with CES-D score of 16 or higher
- Psychiatric hospitalization within 1 year
- High suicide risk score at enrollment
- Unable to provide consent
- Incarcerated individuals
- Pregnant females or those not using highly effective contraception during the study period (failure rate below 1%)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - 12 weeks
Participants receive varenicline-based smoking cessation treatment starting with standard dosing. Those who continue to smoke after 6 weeks are randomized to either increased varenicline dosing, combination therapy with bupropion, or continuation of standard dosing for an additional 6 weeks.
1 baseline visit and periodic visits during treatment
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
Loading map...
Research Team
S
Shelly Ward
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial.
Paul M Cinciripini, Charles E Green, Sanjay Shete...
https://pubmed.ncbi.nlm.nih.gov/38696203