Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-24 @ 10:41 AM
Study NCT ID:
NCT01689168
Status:
TERMINATED
Last Update Posted:
2015-05-20
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D026882', 'term': 'Manipulation, Chiropractic'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Funding ran out', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tobacco cessation', 'timeFrame': 'Smoking diary will be complete for 3 months', 'description': 'Has the subject quit smoking?'}, {'measure': 'Urinary cotinine', 'timeFrame': 'Baseline, 14, 30, 60 and 90 days', 'description': 'An urinary test for nicotine metabolites'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Baseline, 14, 30, 60 days'}, {'measure': 'Weight', 'timeFrame': 'Baseline, 14, 30, 60 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'Tobacco use is the number one killer of Americans today. Most current smokers have tried and failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and withdrawal from smoking can lead to physical symptoms such as irritability, anxiety, nervousness, depression and insomnia.\n\nThis study will examine the effects of tobacco cessation counseling and chiropractic treatments on smokers who desire to quit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 yrs and above\n* Smokers with desire to quit smoking\n\nExclusion Criteria:\n\n* Received chiropractic treatment or other manipulative therapies within the last month\n* Have received any therapy for smoking cessation during the last month\n* Visceral, systemic or joint inflammatory disease\n* A history of low back surgery\n* Osteoporosis\n* Prolonged systemic corticosteroid medication\n* Pregnancy\n* Recent spinal fracture'}, 'identificationModule': {'nctId': 'NCT01689168', 'briefTitle': 'Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Southern California University of Health Sciences'}, 'officialTitle': 'Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ROSE004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Counseling plus chiropractic adjustments', 'interventionNames': ['Behavioral: Counseling', 'Procedure: Chiropractic adjustment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Counseling alone', 'interventionNames': ['Behavioral: Counseling']}], 'interventions': [{'name': 'Counseling', 'type': 'BEHAVIORAL', 'description': 'Tobacco cessation counseling', 'armGroupLabels': ['Counseling alone', 'Counseling plus chiropractic adjustments']}, {'name': 'Chiropractic adjustment', 'type': 'PROCEDURE', 'description': 'Full spine high velocity, low amplitude manipulation of the spine', 'armGroupLabels': ['Counseling plus chiropractic adjustments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90604', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'University Health Center - Whittier', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}], 'overallOfficials': [{'name': 'Kevin A Rose, DC, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern California University of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern California University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'KevinRose', 'investigatorAffiliation': 'Southern California University of Health Sciences'}}}}