A Study of Varenicline in the Treatment of Visceral Sensation

Phase 1

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Varenicline

• Registration Number: NCT06854406
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Study Start: 2025-05-08
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Varenicicline	Varenicline	Varenicline is a α4β2 and α6β2 partial agonist. Varenicline (Chantix) is an FDA-approved partial agonist at α4β2 and α6β2 nAChRs with documented efficacy in the management of chronic pain associated with opioid withdrawal

Primary Outcome Measures

Name	Time	Method
Rectal compliance	Comparison on day 8 of vareniciline treatment compared to baseline	Pressure-volume relationship of rectum during balloon distension
Rectal sensation thresholds during ascending method of limits	Comparison on day 8 of vareniciline treatment compared to baseline	Report of rectal sensation during balloon distension 0-44mmHg
Rectal sensation ratings during random order, graded phasic distensions	Comparison on day 8 of vareniciline treatment compared to baseline	Report of rectal sensation during balloon distensions

Secondary Outcome Measures

Name	Time	Method
Safety/adverse effects	8 days	Safety/adverse effects during administration of varenicicline

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States