Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-03-07 @ 11:59 PM
Study NCT ID:
NCT06854406
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Varenicline in the Treatment of Visceral Sensation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rectal compliance', 'timeFrame': 'Comparison on day 8 of vareniciline treatment compared to baseline', 'description': 'Pressure-volume relationship of rectum during balloon distension'}, {'measure': 'Rectal sensation thresholds during ascending method of limits', 'timeFrame': 'Comparison on day 8 of vareniciline treatment compared to baseline', 'description': 'Report of rectal sensation during balloon distension 0-44mmHg'}, {'measure': 'Rectal sensation ratings during random order, graded phasic distensions', 'timeFrame': 'Comparison on day 8 of vareniciline treatment compared to baseline', 'description': 'Report of rectal sensation during balloon distensions'}], 'secondaryOutcomes': [{'measure': 'Safety/adverse effects', 'timeFrame': '8 days', 'description': 'Safety/adverse effects during administration of varenicicline'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBS', 'pain'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants will be 18-70 years of age\n2. Irritable bowel syndrome with pain, but no constipation \\[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\\]\n\nExclusion Criteria:\n\n1. Diagnosis of moderate-severe depression as per HADS\\>8\n2. Alcohol or illicit substance dependence or abuse in the past 12 months\n3. Dementia, unprovoked seizure history, seizure disorder\n4. 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)\n5. 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\n6. Medically unstable\n7. 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\n8. Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers\n\nNote: Other protocol defined Inclusion/Exclusion Criteria may apply.\n\nEligibility last updated 12/27/2024. Questions regarding updates should be directed to the study team contact.'}, 'identificationModule': {'nctId': 'NCT06854406', 'briefTitle': 'A Study of Varenicline in the Treatment of Visceral Sensation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Varenicline in the Treatment of Visceral Sensation: A Pilot Study', 'orgStudyIdInfo': {'id': '24-013815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varenicicline', 'description': 'Varenicline is a α4β2 and α6β2 partial agonist.\n\nVarenicline (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', 'interventionNames': ['Drug: Varenicline']}], 'interventions': [{'name': 'Varenicline', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Varenicicline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irene Busciglio, BS', 'role': 'CONTACT', 'email': 'busciglio.irene@mayo.edu', 'phone': '507-284-2511'}, {'name': 'Michael Camilleri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael Camilleri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Camilleri, MD', 'investigatorAffiliation': 'Mayo Clinic'}}}}