About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
Disqualifiers
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).
Trial design
Sequential
Treatments tested in this trial
Standard Varenicline Dosing (1 mg BID)
DrugVarenicline PO (oral) 1mg twice daily
Bupropion 150 mg twice daily
DrugBupropion 150 mg PO twice daily
Increased Varenicline Dosing (1mg TID)
DrugVarenicline 1mg PO (oral) three times daily
Treatment groups
Trial outcomes
Primary outcomes
Proportion 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.
Secondary outcomes
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.
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.
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.
Treatment Engagement and Retention
What proportion of participants adhered to the study protocol and continued with the study until completion
Sponsors and contacts
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