A Study of Varenicline in the Treatment of Visceral Sensation

Who can take part

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

Who cannot take part

• 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)
• 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
• 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
• Dementia, unprovoked seizure history, seizure disorder
• 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
• Diagnosis of moderate-severe depression as per HADS\>8
• Alcohol or illicit substance dependence or abuse in the past 12 months
• Medically unstable