Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-02-03 @ 4:23 PM
Study NCT ID:
NCT03734666
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Sponsor:
Organization:
Raw JSON
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Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 1, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'General Disorders and administration site conditions - Other', 'notes': 'Participant was admitted to hospital, but did not disclose why', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Torn Ligament', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aim 2: Number of Participants Scoring >3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - 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Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson \\& Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied). Results reported indicate clients with a patient satisfaction score over 80%.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed who responded to the survey'}, {'type': 'PRIMARY', 'title': 'Aim 2: Rate of Recruitment of Eligible Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligilible Recruited Participants', 'description': 'Participants were mainly recruited via Trialfacts (a recruitment company that utilized online ads, primarily Facebook and Google ads) and Craigslist ads in Florida and Georgia.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20 weeks', 'description': 'Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week', 'unitOfMeasure': 'participants recruited per week', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Aim 2: Participant Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of study at Week 16 Follow-up', 'description': 'Percentage of participants retained through follow-up', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Aim 2: Percentage of Participants That Completed Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}, {'value': '31.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of study at Week 16 Follow-up', 'description': 'Percentage of participants who completed questionnaires at week 16', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aim 3: Percent of Smoking Abstinence End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment at 8 Weeks', 'description': 'Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-responders assumed to be smoking'}, {'type': 'SECONDARY', 'title': 'Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 16 week follow-up', 'description': 'Percent of smoking abstinence, measured by biochemical verification of abstinence via saliva continine and self-report of no smoking in the past 7 days. Participants who report abstinence will be mailed a saliva continine kit to confirm abstinence at their 16 week follow up call.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-responders assumed to be smoking'}, {'type': 'SECONDARY', 'title': 'Aim 3: Percent of Heavy Alcohol Use at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Treatment at 8 Weeks', 'description': 'Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.', 'unitOfMeasure': 'percentage of heavy drinking days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 16 week follow-up', 'description': 'Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.', 'unitOfMeasure': 'percentage of heavy drinking days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'FG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).\n\nMindfulness Based Relapse Prevention - Smoking and Alcohol: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.'}, {'id': 'BG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy 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[{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Transgender Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-01', 'size': 773854, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-21T13:21', 'hasProtocol': True}, {'date': '2021-01-20', 'size': 567198, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-10T14:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'dispFirstSubmitDate': '2022-11-01', 'completionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2018-11-05', 'dispFirstSubmitQcDate': '2022-11-01', 'resultsFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2018-11-06', 'dispFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-09', 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aim 2: Number of Participants Scoring >3', 'timeFrame': 'End of Treatment at 8 Weeks', 'description': 'Number of participants scoring \\>3. Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson \\& Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied). Results reported indicate clients with a patient satisfaction score over 80%.'}, {'measure': 'Aim 2: Rate of Recruitment of Eligible Participants', 'timeFrame': '20 weeks', 'description': 'Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week'}, {'measure': 'Aim 2: Participant Retention', 'timeFrame': 'End of study at Week 16 Follow-up', 'description': 'Percentage of participants retained through follow-up'}, {'measure': 'Aim 2: Percentage of Participants That Completed Questionnaires', 'timeFrame': 'End of study at Week 16 Follow-up', 'description': 'Percentage of participants who completed questionnaires at week 16'}], 'secondaryOutcomes': [{'measure': 'Aim 3: Percent of Smoking Abstinence End of Treatment', 'timeFrame': 'End of Treatment at 8 Weeks', 'description': 'Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.'}, {'measure': 'Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up', 'timeFrame': 'At 16 week follow-up', 'description': 'Percent of smoking abstinence, measured by biochemical verification of abstinence via saliva continine and self-report of no smoking in the past 7 days. Participants who report abstinence will be mailed a saliva continine kit to confirm abstinence at their 16 week follow up call.'}, {'measure': 'Aim 3: Percent of Heavy Alcohol Use at End of Treatment', 'timeFrame': 'End of Treatment at 8 Weeks', 'description': 'Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.'}, {'measure': 'Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up', 'timeFrame': 'At 16 week follow-up', 'description': 'Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol drinking', 'quit smoking'], 'conditions': ['Tobacco Use', 'Alcohol Use, Unspecified']}, 'referencesModule': {'references': [{'pmid': '36645978', 'type': 'DERIVED', 'citation': 'Vinci C, Sutton SK, Yang MJ, Baban S, Sauls R, Witkiewitz K, Brandon KO, Unrod M, Brandon TH, Wetter DW. Pilot randomized controlled trial of mindfulness-based relapse prevention vs cognitive behavioral therapy for smoking and alcohol use. Drug Alcohol Depend. 2023 Mar 1;244:109768. doi: 10.1016/j.drugalcdep.2023.109768. Epub 2023 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.', 'detailedDescription': 'This study evaluates a mindfulness-based treatment to concurrently target cigarette smoking and alcohol use behaviors in adults.\n\nAim 1: Modify an existing mindfulness-based treatment to include a focus on smoking cessation and reduced alcohol use.\n\nAim 2: Evaluate benchmarks regarding the feasibility and acceptability of Mindfulness Based Relapse Prevention -Smoking and Alcohol Use.\n\nAim 3: Collect and examine descriptive data on proximal and distal variables associated with increased smoking abstinence and reduced drinking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Aim 1:\n\n* 18 years of age or older\n* Currently smoking 3 or more cigarettes per day for the past year.\n* Carbon monoxide level \\>/= 8 ppm(parts per million); should carbon monoxide level yield a result less than 8 ppm, participant will be asked to submit a urine sample to determine contine levels and the result must be \\>/ level 3\n* Participant must be motivated to quit smoking and decrease alcohol use within the next 60 days\n* If male, consume \\>/= 5 drinks and if female consume \\>/= 4 drinks on at least 1 occasion in the past month\n* Willing and able to attend the 8 weekly group sessions\n* Valid home address in the Tampa Bay area\n* Functioning telephone number\n* Can speak, read and write in English\n\nInclusion Criteria Aim 2:\n\n* 18 years of age or older\n* Currently smoking 3 or more cigarettes per day for the past year.\n* Motivated to quit smoking and decrease alcohol use within the next 60 days\n* If male, consumes \\>/= 5 drinks and if female consumes \\>/= 4 drinks on at least 1 occasion in the past month\n* Willingness and ability to attend 8 weekly video group sessions\n* Willingness and ability to use an email account for study materials\n* Valid address\n* Functioning telephone number\n* Can speak, read and write in English\n\nExclusion Criteria:\n\n* Unable to wear nicotine patch\n* Participants who have an active substance use disorder other than an alcohol use disorder\n* Participants who have an active psychotic disorder\n* Current use of tobacco cessation medications\n* Pregnant or nursing\n* Participants who have a household member already enrolled in the study.\n* In rare cases, study staff might exclude a participant for a reason not specified here'}, 'identificationModule': {'nctId': 'NCT03734666', 'briefTitle': 'Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation', 'orgStudyIdInfo': {'id': 'MCC-19630'}, 'secondaryIdInfos': [{'id': 'R34AT009689', 'link': 'https://reporter.nih.gov/quickSearch/R34AT009689', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Based Relapse Prevention', 'description': 'Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).', 'interventionNames': ['Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy', 'description': 'Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Mindfulness Based Relapse Prevention - Smoking and Alcohol', 'type': 'BEHAVIORAL', 'otherNames': ['MBRP'], 'description': 'Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.', 'armGroupLabels': ['Mindfulness Based Relapse Prevention']}, {'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.', 'armGroupLabels': ['Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Christine Vinci, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}