A Study of Varenicline in the Treatment of Visceral Sensation

Description

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.

Conditions

Irritable Bowel Syndrome

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Study Overview

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Study Details

Study overview

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.

Varenicline in the Treatment of Visceral Sensation: A Pilot Study

A Study of Varenicline in the Treatment of Visceral Sensation

Condition
Irritable Bowel Syndrome
Intervention / Treatment

-

Contacts and Locations

Rochester

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants will be 18-70 years of age
  • 2. Irritable bowel syndrome with pain, but no constipation \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\]
  • 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Michael Camilleri, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-12-31