Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07171112
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreatitis, Acute
  • Pancreatitis, Chronic
  • Recurrent Acute Pancreatitis
  • Smoking (Tobacco) Addiction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Nov 6, 2025
Status verified
Nov 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Continuation of standard varenicline dosing (1mg BID)
    1\. A group that continues to take varenicline 1mg twice a day (no change)
  • Experimental: Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID
    A group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID)
  • Experimental: Increased Varenicline Dosing (1 mg TID)
    A group assigned to increased varenicline (1mg oral three times a day) dosing

Primary Outcome Measure

Proportion of participants who quit smoking at 12 weeks of treatment [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55902
Shelly Ward
[email protected]
507-293-5574

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Mayo Clinic· Rochester, MN

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