Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-27 @ 4:40 AM
Study NCT ID:
NCT03163303
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Smoking Tobacco and Drinking Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'derek.satre@ucsf.edu', 'phone': '(415) 476-7382', 'title': 'Dr. Derek Satre', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Self-reported vaping frequency may have impacted biochemically verified nicotine abstinence validity'}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year', 'description': 'Non-serious adverse events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post baseline', 'description': 'Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 3 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \\<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the Month 3 assessment'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post baseline', 'description': 'Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 6 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \\<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the Month 6 assessment'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post baseline', 'description': 'Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 12 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \\<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the Month 12 assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Reduction in Cigarettes Smoked Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6, and 12 months post baseline', 'description': 'A reduction was defined as the number of cigarettes smoked in past 7 days prior to the assessment by 50% or more compared to baseline number of cigarettes at 3, 6, and 12 month', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6, and 12 month post-baseline', 'description': 'An attempt was defined by the participants response to the a question as to whether or not they had made an attempt to quit smoking during the course of treatment at the 3, 6, and 12 months post-baseline assessments. Participants who were determined to have made an attempt at least once during the entire course of treatment were scored as yes or no.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants complete the assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Readiness to change tobacco use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy smokers participating in brief intervention and the tobacco item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit smoking in next 30 days (or is already). Number of participants ready to change smoking in the next month assessed at 3, 6, and 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the assessment'}, {'type': 'SECONDARY', 'title': 'Average Score on the Thoughts About Abstinence Questionnaire (Smoking)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Desire to quit', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Expected success', 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Expected difficulty', 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline', 'description': 'The Thoughts About Abstinence Questionnaire (TAAS, (Hall et al., 1991) is a 3 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty) was assessed at baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Number of Days of Heavy Episodic Drinking (HED) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '4.8', 'spread': '7', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '3.8', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '6', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '3.2', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'HED is defined as the number of days in the past month with 4+ drinks consumed in a a single occasion for women and 5+ drinks for men. HED was assessed at 3, 6 and 12 months.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the assessment'}, {'type': 'SECONDARY', 'title': 'Median Number of Drinks Per Week Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '17'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7.8'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'The number of drinks per week was defined as drinks per week in the past 30 days and assessed at the 3,6,and 12 month assessments.', 'unitOfMeasure': 'drinks per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the assessment'}, {'type': 'SECONDARY', 'title': 'Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '5', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': "Misuse of alcohol in the past year was assessed by the AUDIT-C. The AUDIT-C is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence) and consists of 3 questions with a total score ranging from 0-12, and generally the higher the score, the more likely it is that a person's drinking is affecting his or her safety. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Participants were given this assessment at months 3, 6, and 12.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the assessment'}, {'type': 'SECONDARY', 'title': 'Alcohol Quit Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Follow-up Drinking Questionnaire will assess the presence and number of 24 hr quit attempts since the last assessment. This assessment will be used to calculate presence of at least one quit attempt in the assessment time period and scored as a yes or no.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'SECONDARY', 'title': 'Readiness to Change Alcohol Use Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Readiness to change alcohol use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy drinkers participating in brief intervention and the alcohol item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit drinking in next 30 days (or is already) Proportion of participants ready to change drinking in the next month assessed at 3, 6, and 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the assessment'}, {'type': 'SECONDARY', 'title': 'Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'The Thoughts About Abstinence Questionnaire (TAAS, (Hall et al., 1991) is a 4 item self-report questionnaire that measures: 1) desire to quit heavy episodic drinking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit; 10 = extremely ...adapted for heavy episodic alcohol use', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'OG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed the assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'FG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants who completed the baseline assessment were randomized to the STAND intervention or Tobacco Status Project (TSP) control conditions 1:1 using blocked random assignment sequence generated by the biostatistician. Randomization was stratified by 2 variables known to be related to outcomes: daily smoking status and readiness to quit smoking'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tobacco Status Project + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'BG001', 'title': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch\n\nTobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nnicotine patch: 14-day supply of nicotine patch'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '2.32', 'groupId': 'BG000'}, {'value': '22.1', 'spread': '2.08', 'groupId': 'BG001'}, {'value': '22.1', 'spread': '2.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Transgender or non-binary', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '171', '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': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '144', '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': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Geographic region', 'classes': [{'title': 'South', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'West', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Midwest', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Northeast', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Cigarettes Smoked in Past 7 days', 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '60.9', 'groupId': 'BG000'}, {'value': '68.6', 'spread': '44.7', 'groupId': 'BG001'}, {'value': '72.6', 'spread': '53.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of cigarettes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Usual Number of Cigarettes per Day', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '6.23', 'groupId': 'BG000'}, {'value': '10.8', 'spread': '7.35', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-08', 'size': 233470, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-09T16:30', 'hasProtocol': False}, {'date': '2016-03-14', 'size': 250616, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-09T16:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2017-05-19', 'resultsFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-10', 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months', 'timeFrame': '3 months post baseline', 'description': 'Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 3 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \\<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers'}, {'measure': 'Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months', 'timeFrame': '6 months post baseline', 'description': 'Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 6 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \\<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers'}, {'measure': 'Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months', 'timeFrame': '12 months post baseline', 'description': 'Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 12 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \\<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Reduction in Cigarettes Smoked Over Time', 'timeFrame': '3, 6, and 12 months post baseline', 'description': 'A reduction was defined as the number of cigarettes smoked in past 7 days prior to the assessment by 50% or more compared to baseline number of cigarettes at 3, 6, and 12 month'}, {'measure': 'Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment', 'timeFrame': '3, 6, and 12 month post-baseline', 'description': 'An attempt was defined by the participants response to the a question as to whether or not they had made an attempt to quit smoking during the course of treatment at the 3, 6, and 12 months post-baseline assessments. Participants who were determined to have made an attempt at least once during the entire course of treatment were scored as yes or no.'}, {'measure': 'Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Readiness to change tobacco use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy smokers participating in brief intervention and the tobacco item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit smoking in next 30 days (or is already). Number of participants ready to change smoking in the next month assessed at 3, 6, and 12 months'}, {'measure': 'Average Score on the Thoughts About Abstinence Questionnaire (Smoking)', 'timeFrame': 'At Baseline', 'description': 'The Thoughts About Abstinence Questionnaire (TAAS, (Hall et al., 1991) is a 3 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty) was assessed at baseline.'}, {'measure': 'Average Number of Days of Heavy Episodic Drinking (HED) Over Time', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'HED is defined as the number of days in the past month with 4+ drinks consumed in a a single occasion for women and 5+ drinks for men. HED was assessed at 3, 6 and 12 months.'}, {'measure': 'Median Number of Drinks Per Week Over Time', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'The number of drinks per week was defined as drinks per week in the past 30 days and assessed at the 3,6,and 12 month assessments.'}, {'measure': 'Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': "Misuse of alcohol in the past year was assessed by the AUDIT-C. The AUDIT-C is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence) and consists of 3 questions with a total score ranging from 0-12, and generally the higher the score, the more likely it is that a person's drinking is affecting his or her safety. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Participants were given this assessment at months 3, 6, and 12."}, {'measure': 'Alcohol Quit Attempt', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Follow-up Drinking Questionnaire will assess the presence and number of 24 hr quit attempts since the last assessment. This assessment will be used to calculate presence of at least one quit attempt in the assessment time period and scored as a yes or no.'}, {'measure': 'Readiness to Change Alcohol Use Over Time', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Readiness to change alcohol use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy drinkers participating in brief intervention and the alcohol item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit drinking in next 30 days (or is already) Proportion of participants ready to change drinking in the next month assessed at 3, 6, and 12 months'}, {'measure': 'Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'The Thoughts About Abstinence Questionnaire (TAAS, (Hall et al., 1991) is a 4 item self-report questionnaire that measures: 1) desire to quit heavy episodic drinking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit; 10 = extremely ...adapted for heavy episodic alcohol use'}, {'measure': 'Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time', 'timeFrame': '3, 6, and 12 months post-baseline', 'description': 'Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco', 'Cigarettes', 'Alcohol', 'Cessation', 'Intervention', 'Young adults', 'Internet', 'Social media'], 'conditions': ['Smoking', 'Heavy Episodic Drinking']}, 'referencesModule': {'references': [{'pmid': '33509414', 'type': 'DERIVED', 'citation': 'Meacham MC, Ramo DE, Prochaska JJ, Maier LJ, Delucchi KL, Kaur M, Satre DD. A Facebook intervention to address cigarette smoking and heavy episodic drinking: A pilot randomized controlled trial. J Subst Abuse Treat. 2021 Mar;122:108211. doi: 10.1016/j.jsat.2020.108211. Epub 2020 Nov 23.'}, {'pmid': '30940206', 'type': 'DERIVED', 'citation': 'Ramo DE, Meacham MC, Kaur M, Corpuz ES, Prochaska JJ, Satre DD. Development of a social media-based intervention targeting tobacco use and heavy episodic drinking in young adults. Addict Sci Clin Pract. 2019 Apr 1;14(1):14. doi: 10.1186/s13722-019-0141-9.'}]}, 'descriptionModule': {'briefSummary': 'This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use. Both groups will be offered a nicotine patch starter kit. The primary outcome is verified 7-day point prevalence abstinence from smoking at 3, 6, and 12 months.', 'detailedDescription': "Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use and heavy episodic drinking, tailored to readiness to quit smoking; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 12 weeks of Facebook-based messages and activities tailored to participants' readiness to quit smoking.\n\nAssessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include measures on smoking and drinking patterns and thoughts about abstinence. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* read English\n* between 18 and 25 years of age\n* indicate they use Facebook "most" (≥ 4) days per week\n* have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week\n* have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.\n\nExclusion Criteria:\n\n* do not read English\n* are not between 18 and 25 years of age\n* indicate they do not use Facebook "most" (≥ 4) days per week\n* have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week\n* have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.'}, 'identificationModule': {'nctId': 'NCT03163303', 'acronym': 'STAND', 'briefTitle': 'Smoking Tobacco and Drinking Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Using Facebook to Address Smoking and Heavy Drinking in Young Adults', 'orgStudyIdInfo': {'id': 'P0509092'}, 'secondaryIdInfos': [{'id': 'R34DA041637', 'link': 'https://reporter.nih.gov/quickSearch/R34DA041637', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobacco Status Project (TSP) + Alcohol Intervention', 'description': 'Tobacco and alcohol intervention on Facebook and 14-day nicotine patch', 'interventionNames': ['Behavioral: Tobacco Status Project + Alcohol Intervention', 'Drug: nicotine patch']}, {'type': 'EXPERIMENTAL', 'label': 'Tobacco Status Project Intervention', 'description': 'Tobacco intervention on Facebook and 14-day nicotine patch', 'interventionNames': ['Behavioral: Tobacco Status Project Intervention', 'Drug: nicotine patch']}], 'interventions': [{'name': 'Tobacco Status Project Intervention', 'type': 'BEHAVIORAL', 'description': '90 days of Facebook messaging, weekly live sessions targeting tobacco use', 'armGroupLabels': ['Tobacco Status Project Intervention']}, {'name': 'Tobacco Status Project + Alcohol Intervention', 'type': 'BEHAVIORAL', 'description': '90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use', 'armGroupLabels': ['Tobacco Status Project (TSP) + Alcohol Intervention']}, {'name': 'nicotine patch', 'type': 'DRUG', 'description': '14-day supply of nicotine patch', 'armGroupLabels': ['Tobacco Status Project (TSP) + Alcohol Intervention', 'Tobacco Status Project Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Department of Psychiatry', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Derek Satre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All data will be de-identified and transferred to Dr. Chris Yang, expert on social media analytics at Drexel University, for analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}