Pancreatitis, ChronicPhase 2NCT07171112
Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis
A Phase 2 study testing Standard Varenicline Dosing (1 mg BID), Bupropion 150 mg twice daily and Increased Varenicline Dosing (1mg TID) in people with Pancreatitis, Chronic and Pancreatitis, Acute, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Chronic, Pancreatitis, Acute, Recurrent Acute Pancreatitis
- What is being tested?
- Standard Varenicline Dosing (1 mg BID), Bupropion 150 mg twice daily and Increased Varenicline Dosing (1mg TID)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to 2 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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)
- Regular use of CYP2D6 substrates with narrow therapeutic indices (e.g. flecainide, propafenone, tricyclic antidepressants such as nortriptyline, thioridazine, vinblastine)
- History of acute angle closure glaucoma
- Meet criteria for depression as assessed by the Center for Epidemiologic Studies - Depression (CES-D) with a score of 16 or higher.
- Psychiatric hospitalization within 1 year of screening
- Participants who have a score of 3 or higher on the Columbus-Suicide Severity Rating Scale (C-SSRS) at enrollment or during any of the study assessments will be excluded
- Unable to provide consent for self Incarcerated
- Pregnant females. All female patients of childbearing potential must have a negative pregnancy test and must agree to use highly effective (failure rate <1%) contraception during participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis
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.
Read the detailed description
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:
- 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.
- Conditions
- Pancreatitis, Chronic, Pancreatitis, Acute, Recurrent Acute Pancreatitis, Smoking (Tobacco) Addiction
- Being tested
- Standard Varenicline Dosing (1 mg BID), Bupropion 150 mg twice daily, Increased Varenicline Dosing (1mg TID)
- Keywords
- Smoking cessation, chronic pancreatitis, recurrent acute pancreatitis, varenicline, bupropion
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis, Smoking, Behavior, Addictive, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Varenicline Dosing (1 mg BID)Drug
Varenicline PO (oral) 1mg twice daily
Bupropion 150 mg twice dailyDrug
Bupropion 150 mg PO twice daily
Increased Varenicline Dosing (1mg TID)Drug
Varenicline 1mg PO (oral) three times daily
| Study group | Role | What they receive |
|---|---|---|
| Continuation of standard varenicline dosing (1mg BID) | Active comparator | 1. A group that continues to take varenicline 1mg twice a day (no change) Receives: 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) Receives: 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 Receives: Drug: Increased Varenicline Dosing (1mg TID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Treatment Engagement and Retention
What proportion of participants adhered to the study protocol and continued with the study until completion
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start6 Nov 2025
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Why it stopped: Unable to recruit eligible participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Han, Mayo Clinic
- Investigators
- Samuel Han, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171112
- Sponsor's protocol ID
- 25-004013
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data including participant and disease characteristics and treatment outcomes will be shared.
Publications
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.
PubMed 24399554Cinciripini 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.
PubMed 38696203
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT07171112
- Acronym / sponsor ID
- 25-004013
- Conditions
- Pancreatitis, Chronic, Pancreatitis, Acute, Recurrent Acute Pancreatitis, Smoking (Tobacco) Addiction
- Keywords
- Smoking cessation, chronic pancreatitis, recurrent acute pancreatitis, varenicline, bupropion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit eligible participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuation of standard varenicline dosing (1mg BID) | Active comparator | Drug: Standard Varenicline Dosing (1 mg BID)1. A group that continues to take varenicline 1mg twice a day (no change) |
| Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID | Experimental | Drug: Standard Varenicline Dosing (1 mg BID), Drug: Bupropion 150 mg twice dailyA group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID) |
| Increased Varenicline Dosing (1 mg TID) | Experimental | Drug: Increased Varenicline Dosing (1mg TID)A group assigned to increased varenicline (1mg oral three times a day) dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Varenicline Dosing (1 mg BID)Varenicline PO (oral) 1mg twice daily | Drug | 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 dailyBupropion 150 mg PO twice daily | Drug | Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID |
| Increased Varenicline Dosing (1mg TID)Varenicline 1mg PO (oral) three times daily | Drug | Increased Varenicline Dosing (1 mg TID) |
Primary outcome
Proportion of participants who quit smoking at 12 weeks of treatment
Time frame: 12 weeks
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.
5 secondary outcomes
Proportion of participants who have quit smoking 24 weeks after treatment initiation
Time frame: 24 weeks
Reduction in Smoking
Time frame: 12 weeks and 24 weeks
Serious quit attempts
Time frame: 12 weeks
Treatment Engagement and Retention
Time frame: 12 weeks
Treatment Acceptability
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 24399554Ebbert 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.
- Background: PubMed 38696203Cinciripini 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.
- Individual participant dataSharing planned: Yes. Deidentified data including participant and disease characteristics and treatment outcomes will be shared.
Related trials for Pancreatitis, Chronic
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Han, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Varenicline Dosing (1 mg BID), Bupropion 150 mg twice daily and Increased Varenicline Dosing (1mg TID) in people with Pancreatitis, Chronic and Pancreatitis, Acute, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who quit smoking at 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07171112, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.