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.
This randomized trial evaluates the safety and efficacy of varenicline-based smoking cessation treatment for patients with recurrent acute pancreatitis and chronic pancreatitis. Participants who currently smoke cigarettes and have a desire to quit smoking will be eligible to participate in this study. Upon providing informed consent, baseline information regarding quality of life, pain, smoking history, and mental health will be collected for each participant in addition to an exhaled carbon monoxide level measurement. Participants will then be started on standard varenicline dosing for smoking cessation (1mg PO BID) for 6 weeks. Participants who continue to smoke (non-abstainers) after 6 weeks will then be randomized into 3 treatment options: 1\) Increased varenicline dosing (1mg PO TID) 2) Combination of varenicline (1mg PO BID) with bupropion (150mg PO BID) or 3) Continued standard dosing of varenicline (1 mg PO BID) for an additional 6 weeks. After 12 weeks of treatment, participants will be asked about their smoking status, have an exhaled carbon monoxide level measured and will repeat their assessments of quality of life, pain, mental health and smoking urges.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Varenicline PO (oral) 1mg twice daily
Bupropion 150 mg PO twice daily
Varenicline 1mg PO (oral) three times daily
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGProportion of participants who quit smoking at 12 weeks of treatment
This outcome measures the number of participants who quit smoking (out of the total number of participants for that intervention arm) after 12 weeks of treatment. Smoking cessation is assessed using a questionnaire that directly asks participants if they have smoked any cigarettes in the last 7 days. Smoking cessation is then confirmed by measuring an exhaled carbon monoxide level using a carbon monoxide monitor.
Time frame: 12 weeks
Proportion of participants who have quit smoking 24 weeks after treatment initiation
This outcome measures the number of participants who have quit smoking (out of the total number of participants for that intervention arm) 24 weeks after starting treatment. Smoking cessation is assessed using a questionnaire that directly asks participants if they have smoked any cigarettes in the last 7 days.
Time frame: 24 weeks
Reduction in Smoking
Number of cigarettes smoked per day. This outcome measures whether there has been any change (decrease) in the number of cigarettes smoked a day.
Time frame: 12 weeks and 24 weeks
Serious quit attempts
Number of attempts where smoking was stopped for at least 24 hours. This outcome measures the number of quitting attempts made by participants during the 12 weeks of treatment.
Time frame: 12 weeks
Treatment Engagement and Retention
What proportion of participants adhered to the study protocol and continued with the study until completion
Time frame: 12 weeks
Treatment Acceptability
This outcome measures whether the assigned treatment was acceptable to participants. This will be assessed using the Treatment Evaluation Inventory - Short Form (score range 9-45, with higher scores representing greater acceptance of the treatment). This questionnaire uses a 5-point scale and contains 9 questions. A total score of 27 or higher would demonstrate moderate treatment acceptability.
Time frame: 12 weeks
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