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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA041637 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
Assessments 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco Status Project (TSP) + Alcohol Intervention | Experimental | Tobacco and alcohol intervention on Facebook and 14-day nicotine patch |
|
| Tobacco Status Project Intervention | Experimental | Tobacco intervention on Facebook and 14-day nicotine patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco Status Project Intervention | Behavioral | 90 days of Facebook messaging, weekly live sessions targeting tobacco use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months | 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 | 3 months post baseline |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months | 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 | 6 months post baseline |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months | 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 | 12 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Reduction in Cigarettes Smoked Over Time | 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 | 3, 6, and 12 months post baseline |
| Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Satre, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Department of Psychiatry | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33509414 | Derived | 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. | |
| 30940206 | Derived | 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. |
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All data will be de-identified and transferred to Dr. Chris Yang, expert on social media analytics at Drexel University, for analysis
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Tobacco Status Project + Alcohol Intervention | Tobacco and alcohol intervention on Facebook and 14-day nicotine patch Tobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use nicotine patch: 14-day supply of nicotine patch |
| FG001 | Tobacco Status Project Intervention | Tobacco intervention on Facebook and 14-day nicotine patch Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use nicotine patch: 14-day supply of nicotine patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tobacco Status Project + Alcohol Intervention | Tobacco and alcohol intervention on Facebook and 14-day nicotine patch Tobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use nicotine patch: 14-day supply of nicotine patch |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months | 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 | Not all participants completed the Month 3 assessment | Posted | Count of Participants | Participants | 3 months post baseline |
|
Up to 1 year
Non-serious adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tobacco Status Project + Alcohol Intervention | Tobacco and alcohol intervention on Facebook and 14-day nicotine patch Tobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use nicotine patch: 14-day supply of nicotine patch |
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Self-reported vaping frequency may have impacted biochemically verified nicotine abstinence validity
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Derek Satre | University of California, San Francisco | (415) 476-7382 | derek.satre@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2018 | Jun 9, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2016 | Jun 9, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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| Tobacco Status Project + Alcohol Intervention | Behavioral | 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use |
|
| nicotine patch | Drug | 14-day supply of nicotine patch |
|
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. |
| 3, 6, and 12 month post-baseline |
| Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time | 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 | 3, 6, and 12 months post-baseline |
| Average Score on the Thoughts About Abstinence Questionnaire (Smoking) | 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. | At Baseline |
| Average Number of Days of Heavy Episodic Drinking (HED) Over Time | 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. | 3, 6, and 12 months post-baseline |
| Median Number of Drinks Per Week Over Time | 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. | 3, 6, and 12 months post-baseline |
| Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time | 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. | 3, 6, and 12 months post-baseline |
| Alcohol Quit Attempt | 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. | 3, 6, and 12 months post-baseline |
| Readiness to Change Alcohol Use Over Time | 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 | 3, 6, and 12 months post-baseline |
| Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time | 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 | 3, 6, and 12 months post-baseline |
| Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time | Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month. | 3, 6, and 12 months post-baseline |
| Tobacco Status Project Intervention |
Tobacco intervention on Facebook and 14-day nicotine patch Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use nicotine patch: 14-day supply of nicotine patch |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Geographic region | Count of Participants | Participants |
|
| Number of Cigarettes Smoked in Past 7 days | Mean | Standard Deviation | number of cigarettes |
|
| Usual Number of Cigarettes per Day | Mean | Standard Deviation | cigarettes per day |
|
| OG001 | Tobacco Status Project Intervention | Tobacco intervention on Facebook and 14-day nicotine patch Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use nicotine patch: 14-day supply of nicotine patch |
|
|
| Primary | Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months | 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 | Not all participants completed the Month 6 assessment | Posted | Count of Participants | Participants | 6 months post baseline |
|
|
|
| Primary | Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months | 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 | Not all participants completed the Month 12 assessment | Posted | Count of Participants | Participants | 12 months post baseline |
|
|
|
| Secondary | Number of Participants With a Reduction in Cigarettes Smoked Over Time | 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 | Not all participants completed the assessment | Posted | Count of Participants | Participants | 3, 6, and 12 months post baseline |
|
|
|
| Secondary | Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment | 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. | Not all participants complete the assessment | Posted | Count of Participants | Participants | 3, 6, and 12 month post-baseline |
|
|
|
| Secondary | Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time | 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 | Not all participants completed the assessment | Posted | Count of Participants | Participants | 3, 6, and 12 months post-baseline |
|
|
|
| Secondary | Average Score on the Thoughts About Abstinence Questionnaire (Smoking) | 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. | Posted | Mean | Standard Deviation | score on a scale | At Baseline |
|
|
|
| Secondary | Average Number of Days of Heavy Episodic Drinking (HED) Over Time | 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. | Not all participants completed the assessment | Posted | Mean | Standard Deviation | days | 3, 6, and 12 months post-baseline |
|
|
|
| Secondary | Median Number of Drinks Per Week Over Time | 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. | Not all participants completed the assessment | Posted | Median | Inter-Quartile Range | drinks per week | 3, 6, and 12 months post-baseline |
|
|
|
| Secondary | Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time | 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. | Not all participants completed the assessment | Posted | Mean | Standard Deviation | score on a scale | 3, 6, and 12 months post-baseline |
|
|
|
| Secondary | Alcohol Quit Attempt | 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. | Data not collected. | Posted | 3, 6, and 12 months post-baseline |
|
|
| Secondary | Readiness to Change Alcohol Use Over Time | 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 | Not all participants completed the assessment | Posted | Count of Participants | Participants | 3, 6, and 12 months post-baseline |
|
|
|
| Secondary | Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time | 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 | Data not collected. | Posted | 3, 6, and 12 months post-baseline |
|
|
| Secondary | Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time | Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month. | Not all participants completed the assessment | Posted | Count of Participants | Participants | 3, 6, and 12 months post-baseline |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 0 |
| EG001 | Tobacco Status Project Intervention | Tobacco intervention on Facebook and 14-day nicotine patch Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use nicotine patch: 14-day supply of nicotine patch | 0 | 94 | 0 | 94 | 0 | 0 |
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| Month 12 |
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| Month 12 |
|
| Expected difficulty |
|
| Month 12 |
|
| Month 12 |
|
| Month 12 |
|
| Month 12 |
|
| Month 12 |
|