Irritable Bowel SyndromePhase 1NCT06854406
A Study of Varenicline in the Treatment of Visceral Sensation
A Phase 1 study testing Varenicline in people with Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Varenicline in the Treatment of Visceral Sensation: A Pilot Study
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
- Being tested
- Varenicline
- Keywords
- IBS, pain
- Medical subject headings
- Irritable Bowel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal compliance
Pressure-volume relationship of rectum during balloon distension
Measured: 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
Measured: 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
Measured: Comparison on day 8 of vareniciline treatment compared to baseline
Secondary outcomes (1)
Safety/adverse effects
Safety/adverse effects during administration of varenicicline
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854406
- Sponsor's protocol ID
- 24-013815
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline in the Treatment of Visceral Sensation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06854406
- Acronym / sponsor ID
- 24-013815
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Varenicicline | Experimental | Drug: VareniclineVarenicline 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)]
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineInitial, 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. | Drug | Varenicicline |
Primary outcome
Rectal compliance
Time frame: 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
Time frame: 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
Time frame: Comparison on day 8 of vareniciline treatment compared to baseline
Report of rectal sensation during balloon distensions
1 secondary outcome
Safety/adverse effects
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varenicline in people with Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectal compliance (time frame: Comparison on day 8 of vareniciline treatment compared to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.