Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Standard Varenicline Dosing (1 mg BID)

    Drug

    Varenicline PO (oral) 1mg twice daily

  • Bupropion 150 mg twice daily

    Drug

    Bupropion 150 mg PO twice daily

  • Increased Varenicline Dosing (1mg TID)

    Drug

    Varenicline 1mg PO (oral) three times daily

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Continuation of standard varenicline dosing (1mg BID)Active comparator 1 intervention
Group B: Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BIDExperimental treatment 2 interventions
Group C: Increased Varenicline Dosing (1 mg TID)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks

Secondary outcomes

1

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
2

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
3

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
4

Treatment Engagement and Retention

What proportion of participants adhered to the study protocol and continued with the study until completion

Time frame
12 weeks

Other outcomes

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