A Study of Varenicline in the Treatment of Visceral Sensation

Launched by MAYO CLINIC · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called varenicline on how people with Irritable Bowel Syndrome (IBS) feel sensations in their rectum. Specifically, it focuses on patients who experience IBS without constipation and have ongoing abdominal pain. The goal is to understand how varenicline might help improve these sensations and provide relief for those suffering from this condition.

To participate in the trial, individuals must be between 18 and 70 years old and diagnosed with IBS that includes diarrhea or mixed symptoms, but not constipation. However, there are some important exclusions: people with moderate to severe depression, a history of substance abuse, certain medical conditions, or some recent changes in medications cannot take part. If eligible, participants will be involved in tests to assess their sensations and can expect regular check-ins throughout the study. Women who can become pregnant will need to take a pregnancy test and use effective contraception during the trial. This study is currently recruiting participants, and if anyone has questions, they can reach out to the study team for more information.

Gender

ALL

Eligibility criteria

• 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.