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Can a double-dose of quit-smoking meds help pancreatitis patients kick the habit?

NCT ID NCT07171112

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study tests whether increasing the dose of varenicline or adding bupropion helps people with recurrent acute or chronic pancreatitis quit smoking. All 45 participants start with standard varenicline; those still smoking after 6 weeks are randomly assigned to a higher dose, a combination, or continued standard dose. Success is measured by self-report and breath carbon monoxide levels at 12 and 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Varenicline and bupropion
What this could lead to
If successful, this could provide a tailored smoking cessation strategy for people with pancreatitis, potentially reducing disease flares and complications.
What could go wrong
This is a small Phase 2 trial with only 45 participants, so results may not apply broadly. The higher drug doses may cause more side effects, and quitting smoking is difficult even with medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Nov 2025

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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: 1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values 2. characteristic cross-sectional imaging 3. 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 Exclusion Criteria * 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) * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

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Other studies related to the condition(s) this trial covers.