Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00006151
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2000-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combining a Smoke Ending Aid With Behavioral Treatment - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gar1iti@mail.med.upenn.edu', 'title': 'Peter Gariti', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Accu Drops (AD&C)', 'description': 'The experimental group (N=30) will be prescribed active Accu Drops (AD\\&C)', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (PD&C)', 'description': 'The control condition (N=30) will be prescribed placebo Accu Drops (PD\\&C)', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abstinence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accu Drop Plus Counseling', 'description': 'Active product and systematic cigarette tapering plus counseling.'}, {'id': 'OG001', 'title': 'Placebo Accu Drop Plus Counseling', 'description': 'Placebo product and systematic cigarette tapering plus counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Accu Drops (AD&C)', 'description': 'The experimental group (N=30) will be prescribed active Accu Drops (AD\\&C)'}, {'id': 'FG001', 'title': 'Placebo (PD&C)', 'description': 'The control condition (N=30) will be prescribed placebo Accu Drops (PD\\&C)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Participants were recruited to a university based center for the study of addictions in 2002.', 'preAssignmentDetails': 'The study used a real world design meaning that participants were randomized on the same day as their study eligibility evaluation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Accu Drop Plus Counseling', 'description': 'Active product and systematic cigarette tapering plus counseling.'}, {'id': 'BG001', 'title': 'Placebo Accu Drop Plus Counseling', 'description': 'Placebo product and systematic cigarette tapering plus counseling'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.07', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '43.50', 'spread': '12', 'groupId': 'BG001'}, {'value': '45.29', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2000-08-08', 'resultsFirstSubmitDate': '2013-06-24', 'studyFirstSubmitQcDate': '2000-08-08', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-15', 'studyFirstPostDateStruct': {'date': '2000-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence Rate', 'timeFrame': '1 year', 'description': 'The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nicotine fading', 'Accu Drop', 'cigarette tapering', 'smoking cessation', 'motivational interviewing'], 'conditions': ['Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '15223089', 'type': 'BACKGROUND', 'citation': 'Gariti P, Alterman AI, Lynch KG, Kampman K, Whittingham T. Adding a nicotine blocking agent to cigarette tapering. J Subst Abuse Treat. 2004 Jul;27(1):17-25. doi: 10.1016/j.jsat.2004.03.005.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to combine a smoke ending aid with behavioral treatment.', 'detailedDescription': 'The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (\\*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD\\&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD\\&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years of age or older, and no greater than 65 years of age\n* Medically stable\n* Smoke at least 15 filtered cigarettes daily\n* Motivated to quit smoking\n\nExclusion Criteria:\n\n* Medically unstable\n* Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT00006151', 'briefTitle': 'Combining a Smoke Ending Aid With Behavioral Treatment - 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Combining a Smoke Ending Aid With Behavioral Treatment', 'orgStudyIdInfo': {'id': 'NIDA-11645-1'}, 'secondaryIdInfos': [{'id': 'R01DA011645', 'link': 'https://reporter.nih.gov/quickSearch/R01DA011645', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accu Drops (AD&C)', 'description': 'The experimental group (N=30) will be prescribed active Accu Drops (AD\\&C) plus behavioral therapy.', 'interventionNames': ['Behavioral: Behavioral Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The control condition (N=30) will be prescribed placebo Accu Drops (PD\\&C) plus behavioral therapy.', 'interventionNames': ['Behavioral: Behavioral Therapy']}], 'interventions': [{'name': 'Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.', 'armGroupLabels': ['Accu Drops (AD&C)', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104 6178', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Peter W Gariti, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Gariti', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Peter Gariti', 'investigatorAffiliation': 'University of Pennsylvania'}}}}