A Study of Varenicline in the Treatment of Visceral Sensation

Inclusion criteria

• 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)]

Exclusion criteria

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