COMPLETED

A Study of Varenicline in the Treatment of Visceral Sensation

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Varenicline in the Treatment of Visceral Sensation: A Pilot Study

Quick Facts

Study Start:2025-06-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06854406

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Michael Camilleri

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Michael Camilleri, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-06-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-06-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

IBS
pain

Additional Relevant MeSH Terms

Irritable Bowel Syndrome