Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-05 @ 6:39 PM
Study NCT ID:
NCT00670904
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2008-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2008-04-30', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Pharmacist-delivered'], 'conditions': ['Tobacco Use Disorder', 'Smoking']}, 'descriptionModule': {'briefSummary': 'This randomized trial compared the effectiveness of a three session pharmacist-delivered group program for smoking versus one 5 to 10 minute standard care session delivered over the telephone on 7-day point prevalence quit rates. Participants in both groups were offered their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established quit date, self-reported cessation was biochemically verified using tests for urinary cotinine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoked one or more cigarettes daily for 7 days\n* Somewhat ready to quit in the next 2 weeks (4 or more on a 10- point scale)\n* Willing and capable of attending three scheduled sessions at the clinic\n* Interested in participating in the study\n\nExclusion Criteria:\n\n* Planned to leave the area in the next 6 months\n* Used pharmacotherapy for smoking cessation in the last 30 days\n* Used other forms of tobacco in the last 30 days\n* Schizophrenia\n* Prior participation'}, 'identificationModule': {'nctId': 'NCT00670904', 'briefTitle': 'Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'University of Montana'}, 'officialTitle': 'Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation', 'orgStudyIdInfo': {'id': 'M29670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Pharmacist-delivered group program for smoking cession.', 'interventionNames': ['Other: Pharmacist-delivered group program for smoking cessation']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Brief standard care session for tobacco smoking cessation delivered over the telephone.', 'interventionNames': ['Other: Brief standard care session for smoking cessation delivered over the telephone']}], 'interventions': [{'name': 'Pharmacist-delivered group program for smoking cessation', 'type': 'OTHER', 'description': 'Participants assigned to the treatment group participated in a pharmacist-delivered program at the clinic. The six-hour program consisted of three in-person sessions delivered at 2-week intervals over 5 weeks to a small group of smokers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.', 'armGroupLabels': ['1']}, {'name': 'Brief standard care session for smoking cessation delivered over the telephone', 'type': 'OTHER', 'description': 'Those assigned to the control group received one 5 to 10 minute session delivered by the clinical pharmacist over the telephone that included all the components of standard care recommended by the Clinical Practice Guidelines for brief interventions delivered by health care providers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Missoula VA Clinic', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}], 'overallOfficials': [{'name': 'Larry A. Dent, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Montana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Montana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prevent Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Larry A. Dent', 'oldOrganization': 'The University of Montana'}}}}