Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 12:17 AM
Study NCT ID:
NCT01351766
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2011-05-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lauramac.phd@gmail.com', 'phone': '6198578425', 'title': 'Laura MacPherson', 'organization': 'University of Maryland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 20 weeks.', 'description': 'Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Behavioral Activation for Smoking', 'description': '* Eight, 60-minute group sessions over an 8 week period\n* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation for Smoking', 'description': '* Eight, 60-minute group sessions over an 8 week period\n* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks post quit date', 'description': '7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Activation for Smoking', 'description': '* Eight, 60-minute group sessions over an 8 week period\n* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Activation for Smoking', 'description': "Behavioral Activation for Smoking (BATSY) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also be provided 8 weeks of the transdermal nicotine patch.\n\nTransdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.00', 'spread': '1.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis population is not different from the assignment in Participant Flow.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2011-05-09', 'resultsFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-09', 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date', 'timeFrame': '12 weeks post quit date', 'description': '7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavioral Activation'], 'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A subset of participants will also undergo an fMRI session to examine reward sensitivity.', 'detailedDescription': '1. 18-21 years of age,\n2. a regular smoker for at least 6 months\n3. currently smoking an average of at least 5 cigarettes per day\n4. want to quit smoking\n5. report current elevated depressive symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '21 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 21 years of age\n* a regular smoker for at least 6 months\n* currently smoking an average of at least 5 cigarettes per day\n* want to quit smoking\n* report current elevated depressive symptoms\n\nExclusion Criteria:\n\n* current Axis I disorder\n* psychoactive substance dependence (excluding nicotine dependence) within the past 6 months\n* current use of psychotropic medication or participation in any form of psychotherapy\n* a history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness\n* limited mental competency \\[Mini Mental State Examination score \\< 23\\] and/or the inability to give informed, voluntary, written consent to participate\n* current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt\n\nAdditional Exclusion criteria only for the fMRI portion:\n\n* cerebrovascular disease\n* high blood pressure\n* diabetes\n* use of psychotropic medications in 3 weeks prior to participation in fMRI protocol\n* exposure to extreme trauma\n* lifetime history of mania, psychosis, or pervasive developmental disorder,\n* being ambidextrous or left handed\n* any metal implants, heart pacemaker, permanent retainer\n* tattoos containing metal dyes\n* claustrophobia.'}, 'identificationModule': {'nctId': 'NCT01351766', 'briefTitle': 'Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, College Park'}, 'officialTitle': 'Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation', 'orgStudyIdInfo': {'id': 'DA029445'}, 'secondaryIdInfos': [{'id': 'R21DA029445', 'link': 'https://reporter.nih.gov/quickSearch/R21DA029445', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Activation for Smoking', 'description': "Eight 60-minute group sessions over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after treatment sessions have ended.\n\nTransdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.", 'interventionNames': ['Drug: Transdermal Nicotine Patch']}], 'interventions': [{'name': 'Transdermal Nicotine Patch', 'type': 'DRUG', 'otherNames': ['Nicoderm CQ'], 'description': "Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.", 'armGroupLabels': ['Behavioral Activation for Smoking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20742', 'city': 'College Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, College Park', 'geoPoint': {'lat': 38.98067, 'lon': -76.93692}}], 'overallOfficials': [{'name': 'Laura MacPherson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, College Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Laura MacPherson', 'investigatorAffiliation': 'University of Maryland, College Park'}}}}