Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis

NCT07171112 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-004013
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Smoking cessation; chronic pancreatitis; recurrent acute pancreatitis; varenicline; bupropion

Outcome Measures

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.

  12 weeks

Secondary Outcomes (5)

• Proportion of participants who have quit smoking 24 weeks after treatment initiation

  24 weeks

• Reduction in Smoking

  12 weeks and 24 weeks

• Serious quit attempts

  12 weeks

• Treatment Engagement and Retention

  12 weeks

• Treatment Acceptability

  12 weeks

Study Arms (3)

Continuation of standard varenicline dosing (1mg BID)

ACTIVE COMPARATOR

1\. A group that continues to take varenicline 1mg twice a day (no change)

Drug: Standard Varenicline Dosing (1 mg BID)

Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID

EXPERIMENTAL

A group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID)

Drug: Standard Varenicline Dosing (1 mg BID); Drug: Bupropion 150 mg twice daily

Increased Varenicline Dosing (1 mg TID)

EXPERIMENTAL

A group assigned to increased varenicline (1mg oral three times a day) dosing

Drug: Increased Varenicline Dosing (1mg TID)

Interventions

Standard Varenicline Dosing (1 mg BID) DRUG

Varenicline PO (oral) 1mg twice daily

Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID; Continuation of standard varenicline dosing (1mg BID)

Bupropion 150 mg twice daily DRUG

Bupropion 150 mg PO twice daily

Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID

Increased Varenicline Dosing (1mg TID) DRUG

Varenicline 1mg PO (oral) three times daily

Increased Varenicline Dosing (1 mg TID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
• characteristic cross-sectional imaging
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Related Publications (2)

• Ebbert JO, Hatsukami DK, Croghan IT, Schroeder DR, Allen SS, Hays JT, Hurt RD. Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA. 2014 Jan 8;311(2):155-63. doi: 10.1001/jama.2013.283185.

  PMID: 24399554 BACKGROUND

• Cinciripini PM, Green CE, Shete S, Minnix JA, Robinson JD, Cui Y, Kim S, Kypriotakis G, Beneventi D, Blalock JA, Versace F, Karam-Hage M. Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial. JAMA. 2024 May 28;331(20):1722-1731. doi: 10.1001/jama.2024.4183.

  PMID: 38696203 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis; Smoking; Behavior, Addictive; Smoking Cessation

Interventions

BID protein, human; Bupropion

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Compulsive Behavior; Impulsive Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Samuel Han, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelly Ward

CONTACT

507-538-9997; Ward.Shelly1@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 12, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 24 months after publication of primary manuscript to 5 years after publication of primary manuscript.
• Access Criteria: Researchers will be able to access the IPD after submitting a proposal that is reviewed and approved by the PI. Deidentified data in accordance to the agreed-upon proposal will be made available to researchers.

Locations

US (1)