A Study of Varenicline in the Treatment of Visceral Sensation

NCT06854406 | Completed Phase 1 FDA Drug

• 1 other identifier: 24-013815
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; pain

Outcome Measures

Primary Outcomes (3)

• Rectal compliance

  Pressure-volume relationship of rectum during balloon distension

  Comparison on day 8 of vareniciline treatment compared to baseline

• Rectal sensation thresholds during ascending method of limits

  Report of rectal sensation during balloon distension 0-44mmHg

  Comparison on day 8 of vareniciline treatment compared to baseline

• Rectal sensation ratings during random order, graded phasic distensions

  Report of rectal sensation during balloon distensions

  Comparison on day 8 of vareniciline treatment compared to baseline

Secondary Outcomes (1)

• Safety/adverse effects

  8 days

Study Arms (1)

Varenicicline

EXPERIMENTAL

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

Drug: Varenicline

Interventions

Varenicline DRUG

Initial, 0.5 mg orally once daily for 3 days, then 0.5 mg every 12 hours on days 4 through 7, and then 1 mg in morning of day 8. Medication is taken after eating and with a full glass of water.

Varenicicline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Eligibility last updated 12/27/2024. Questions regarding updates should be directed to the study team contact.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Pain

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Michael Camilleri

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 3, 2025
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)