A Study of Varenicline in the Treatment of Visceral Sensation

January 2, 2026 updated by: Michael Camilleri, MD, Mayo Clinic

Varenicline in the Treatment of Visceral Sensation: A Pilot Study

The purpose of this study is to evaluate the effect of varenicline on rectal sensation, based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation IBS and chronic abdominal pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicicline

Varenicline is a α4β2 and α6β2 partial agonist.

Varenicline (Chantix) is an FDA-approved partial agonist at α4β2 and α6β2 nAChRs with documented efficacy in the management of chronic pain associated with opioid withdrawal
Drug: Varenicline
Initial, 0.5 mg orally once daily for 3 days, then 0.5 mg every 12 hours on days 4 through 7, and then 1 mg in morning of day 8. Medication is taken after eating and with a full glass of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rectal compliance
Time Frame: Comparison on day 8 of vareniciline treatment compared to baseline
Pressure-volume relationship of rectum during balloon distension
Comparison on day 8 of vareniciline treatment compared to baseline
Rectal sensation thresholds during ascending method of limits
Time Frame: Comparison on day 8 of vareniciline treatment compared to baseline
Report of rectal sensation during balloon distension 0-44mmHg
Comparison on day 8 of vareniciline treatment compared to baseline
Rectal sensation ratings during random order, graded phasic distensions
Time Frame: Comparison on day 8 of vareniciline treatment compared to baseline
Report of rectal sensation during balloon distensions
Comparison on day 8 of vareniciline treatment compared to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/adverse effects
Time Frame: 8 days
Safety/adverse effects during administration of varenicicline
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Michael Camilleri, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-013815

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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