Evaluating varenicline for treating visceral sensation in IBS
Varenicline in the Treatment of Visceral Sensation: A Pilot Study
This study is testing if a medication called varenicline can help adults with irritable bowel syndrome and chronic abdominal pain feel less discomfort in their rectal area.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06854406 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effects of varenicline on rectal sensation in individuals suffering from non-constipation irritable bowel syndrome (IBS) and chronic abdominal pain. Participants will undergo evaluations using the ascending method of limits and graded rapid phasic distensions to measure changes in sensation. The study is designed for adults aged 18 to 70 who meet specific criteria related to their IBS condition. The primary focus is on understanding how varenicline may alleviate pain associated with IBS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with non-constipation IBS and chronic abdominal pain.
Not a fit: Patients with moderate to severe depression, substance dependence, or significant medical instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from chronic abdominal pain related to IBS.
How similar studies have performed: While this approach is novel in the context of IBS treatment, similar studies have shown promise in using varenicline for other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael Camilleri — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.