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Could a smoking-cessation pill calm IBS pain? tiny study explores varenicline

NCT ID NCT06854406

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether varenicline, a drug used to help people quit smoking, can change how the rectum senses pressure in people with irritable bowel syndrome (IBS) who have chronic belly pain. Eight adults with IBS (but not the constipation type) took the drug for 8 days while researchers measured rectal sensation using a balloon. The goal was to see if the drug affects pain signals from the gut.

What this could mean

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

Active substance
Varenicline
What this could lead to
If it works, this could point toward a new way to ease abdominal pain in people with irritable bowel syndrome.
What could go wrong
This is a very small, early pilot study with only 8 people. It may not show clear benefits, and varenicline can have side effects like nausea or mood changes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Jun 2025

Finished

Dec 2025

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 to 70 years

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: 1. Participants will be 18-70 years of age 2. Irritable bowel syndrome with pain, but no constipation \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\] Exclusion Criteria: 1. Diagnosis of moderate-severe depression as per HADS\>8 2. Alcohol or illicit substance dependence or abuse in the past 12 months 3. Dementia, unprovoked seizure history, seizure disorder 4. Pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form) 5. Significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks 6. Medically unstable 7. Severe hepatic or renal impairment, such as baseline AST or ALT \>2.5 X upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance \<15 mL/min 8. Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers Note: Other protocol defined Inclusion/Exclusion Criteria may apply. Eligibility last updated 12/27/2024. Questions regarding updates should be directed to the study team contact.

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome Pain

As listed by the trial registrant

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

Irritable bowel syndrome

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

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