Smoking cessation for people with recurrent acute or chronic pancreatitis
Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis
This trial tests whether increasing the dose of varenicline or adding bupropion helps adults with chronic or recurrent acute pancreatitis who still smoke cigarettes quit smoking.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07171112 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 2 trial starts all participants on standard varenicline for six weeks with baseline measures of breath carbon monoxide, quality of life, pain, smoking history, and mental health. Participants who continue to smoke at six weeks are randomized to either higher-dose varenicline (1 mg TID), varenicline plus bupropion (150 mg BID), or continuation of standard varenicline (1 mg BID) for an additional six weeks. Smoking abstinence is confirmed at 12 weeks by exhaled carbon monoxide and repeated assessments of quality of life, pain, mental health, and smoking urges. The study examines safety and short-term efficacy of varenicline-based strategies specifically in people with recurrent acute or chronic pancreatitis.
Who should consider this trial
Good fit: Adults (age ≥18) with a diagnosis of recurrent acute pancreatitis or chronic pancreatitis who currently smoke at least 5 cigarettes per day and want to quit are ideal candidates.
Not a fit: Patients who have already quit, who cannot tolerate varenicline or bupropion, or who are unable to attend in-person visits at the study site may not receive benefit from this trial.
Why it matters
Potential benefit: If successful, the interventions could increase quit rates and potentially reduce pancreatitis flares and related symptoms.
How similar studies have performed: Varenicline and bupropion are effective smoking-cessation medications in general populations, but there are limited data specifically in patients with pancreatitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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: 1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values 2. characteristic cross-sectional imaging 3. 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 Exclusion Criteria * Age \< 18 years * Ongoing acute pancreatitis or prior episode of pancreatitis in previous 30 days * No desire to quit smoking * Currently undergoing smoking cessation intervention (i.e. nicotine replacement therapy, varenicline, counseling, bupropion). * Known allergic reactions to varenicline or bupropion SR * History of seizures * History of an eating disorder (anorexia or bulimia) * Closed head trauma with any loss of consciousness or amnesia in the last 5 year * Ever history of closed head trauma with \> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion * Ever history of alcohol withdrawal * Ever history of chronic kidney disease (creatine clearance \< 30 mL/minute) * Liver impairment (i.e. history of cirrhosis) with aminotransferase elevation ≥ 2 times the upper limit of normal and/or alkaline phosphatase elevation ≥ 2 times the upper limit of normal. * History of bipolar disorder or psychosis * Ongoing or recent use (prior 14 days) of any monoamine oxidase inhibitors (isocarboxazid, phenelzine, tranylcypromine, selegiline). * Regular use of potent CYP2B6 inhibitors (i.e. clopidogrel, ticlopidine) * Regular use of CYP2D6 substrates with narrow therapeutic indices (e.g. flecainide, propafenone, tricyclic antidepressants such as nortriptyline, thioridazine, vinblastine) * History of acute angle closure glaucoma * Meet criteria for depression as assessed by the Center for Epidemiologic Studies - Depression (CES-D) with a score of 16 or higher. * Psychiatric hospitalization within 1 year of screening * Participants who have a score of 3 or higher on the Columbus-Suicide Severity Rating Scale (C-SSRS) at enrollment or during any of the study assessments will be excluded * Unable to provide consent for self Incarcerated * Pregnant females. All female patients of childbearing potential must have a negative pregnancy test and must agree to use highly effective (failure rate \<1%) contraception during participation in the study.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Han, MD — Mayo Clinic
- Study coordinator: Shelly Ward
- Email: Ward.Shelly1@mayo.edu
- Phone: 507-538-9997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.