STAND: Smoking Tobacco and Drinking Study

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT03163303
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 179
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.4
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking; Heavy Episodic Drinking	Behavioral: Tobacco Status Project Intervention; Behavioral: Tobacco Status Project + Alcohol Intervention; Drug: nicotine patch	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Using Facebook to Address Smoking and Heavy Drinking in Young Adults
• Actual Study Start Date: Dec 18, 2017
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tobacco Status Project (TSP) + Alcohol Intervention Tobacco and alcohol intervention on Facebook and 14-day nicotine patch	Behavioral: Tobacco Status Project + Alcohol Intervention; 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use; Drug: nicotine patch; 14-day supply of nicotine patch
Experimental: Tobacco Status Project Intervention Tobacco intervention on Facebook and 14-day nicotine patch	Behavioral: Tobacco Status Project Intervention; 90 days of Facebook messaging, weekly live sessions targeting tobacco use; Drug: nicotine patch; 14-day supply of nicotine patch

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months [3 months post baseline]

   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

2. Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months [6 months post baseline]

   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

3. Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months [12 months post baseline]

   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

Secondary Outcome Measures

1. Number of Participants With a Reduction in Cigarettes Smoked Over Time [3, 6, and 12 months post baseline]

   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

2. Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment [3, 6, and 12 month post-baseline]

   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. Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time [3, 6, and 12 months post-baseline]

   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

4. Average Score on the Thoughts About Abstinence Questionnaire (Smoking) [At Baseline]

   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.

5. Average Number of Days of Heavy Episodic Drinking (HED) Over Time [3, 6, and 12 months post-baseline]

   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.

6. Median Number of Drinks Per Week Over Time [3, 6, and 12 months post-baseline]

   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.

7. Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time [3, 6, and 12 months post-baseline]

   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.

8. Alcohol Quit Attempt [3, 6, and 12 months post-baseline]

   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.

9. Readiness to Change Alcohol Use Over Time [3, 6, and 12 months post-baseline]

   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

10. Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time [3, 6, and 12 months post-baseline]

    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

11. Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time [3, 6, and 12 months post-baseline]

    Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• read English

• between 18 and 25 years of age

• indicate they use Facebook "most" (≥ 4) days per week

• have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week

• have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

Exclusion Criteria:

• do not read English

• are not between 18 and 25 years of age

• indicate they do not use Facebook "most" (≥ 4) days per week

• 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

• have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco Department of Psychiatry	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Derek Satre, PhD, University of California, San Francisco

Study Documents (Full-Text)

• Informed Consent Form - Feb 8, 2018
• Study Protocol and Statistical Analysis Plan - Mar 14, 2016

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03163303
• Other Study ID Numbers: P0509092; R34DA041637
• First Posted: May 23, 2017
• Last Update Posted: Aug 12, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of California, San Francisco: Tobacco; Cigarettes; Alcohol; Cessation; Intervention; Young adults; Internet; Social media
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Pre-assignment Detail	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

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	85	94
COMPLETED	85	94
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	85	94	179
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.1 (2.32)	22.1 (2.08)	22.1 (2.20)
Sex/Gender, Customized (Count of Participants)
Female	33 38.8%	49 52.1%	82 45.8%
Male	40 47.1%	39 41.5%	79 44.1%
Transgender or non-binary	12 14.1%	6 6.4%	18 10.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 7.1%	2 2.1%	8 4.5%
Not Hispanic or Latino	79 92.9%	92 97.9%	171 95.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 7.1%	7 7.4%	13 7.3%
Asian	1 1.2%	5 5.3%	6 3.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 2.4%	2 2.1%	4 2.2%
White	66 77.6%	78 83%	144 80.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	10 11.8%	2 2.1%	12 6.7%
Region of Enrollment (participants) [Number]
United States	85 100%	94 100%	179 100%
Geographic region (Count of Participants)
South	28 32.9%	28 29.8%	56 31.3%
West	21 24.7%	25 26.6%	46 25.7%
Midwest	20 23.5%	24 25.5%	44 24.6%
Northeast	16 18.8%	17 18.1%	33 18.4%
Number of Cigarettes Smoked in Past 7 days (number of cigarettes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of cigarettes]	76.2 (60.9)	68.6 (44.7)	72.6 (53.8)
Usual Number of Cigarettes per Day (cigarettes per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cigarettes per day]	10.1 (6.23)	10.8 (7.35)	10.4 (6.9)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months
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
Time Frame	3 months post baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the Month 3 assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	69	79
Count of Participants [Participants]	3 3.5%	4 4.3%

2. Primary Outcome

Title	Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months
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
Time Frame	6 months post baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the Month 6 assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	53	61
Count of Participants [Participants]	0 0%	1 1.1%

3. Primary Outcome

Title	Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months
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
Time Frame	12 months post baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the Month 12 assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	70	81
Count of Participants [Participants]	3 3.5%	0 0%

4. Secondary Outcome

Title	Number of Participants With a Reduction in Cigarettes Smoked Over Time
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
Time Frame	3, 6, and 12 months post baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Month 3	32 37.6%	35 37.2%
Month 6	35 41.2%	30 31.9%
Month 12	46 54.1%	46 48.9%

5. Secondary Outcome

Title	Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
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.
Time Frame	3, 6, and 12 month post-baseline

Outcome Measure Data

Analysis Population Description

Not all participants complete the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Count of Participants [Participants]	49 57.6%	45 47.9%

6. Secondary Outcome

Title	Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time
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
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Month 3	37 43.5%	27 28.7%
Month 6	20 23.5%	23 24.5%
Month 12	34 40%	41 43.6%

7. Secondary Outcome

Title	Average Score on the Thoughts About Abstinence Questionnaire (Smoking)
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.
Time Frame	At Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	85	94
Desire to quit	6.1 (2.6)	5.9 (2.5)
Expected success	4.6 (2.3)	5.1 (2.6)
Expected difficulty	7.2 (2.4)	7.1 (2.3)

8. Secondary Outcome

Title	Average Number of Days of Heavy Episodic Drinking (HED) Over Time
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.
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Month 3	4.8 (7)	7.6 (8.2)
Month 6	3.8 (5.5)	6 (7.8)
Month 12	3.2 (5.2)	5.6 (7.6)

9. Secondary Outcome

Title	Median Number of Drinks Per Week Over Time
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.
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Month 3	4	6
Month 6	5	7
Month 12	1	4

10. Secondary Outcome

Title	Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time
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.
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Month 3	3.9 (2.7)	5 (2.9)
Month 6	3.7 (2.7)	4.8 (3)
Month 12	3.4 (2.4)	4.1 (3.1)

11. Secondary Outcome

Title	Alcohol Quit Attempt
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.
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	0	0

12. Secondary Outcome

Title	Readiness to Change Alcohol Use Over Time
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
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Month 3	40 47.1%	42 44.7%
Month 6	28 32.9%	38 40.4%
Month 12	42 49.4%	54 57.4%

13. Secondary Outcome

Title	Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time
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
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	0	0

14. Secondary Outcome

Title	Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time
Description	Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month.
Time Frame	3, 6, and 12 months post-baseline

Outcome Measure Data

Analysis Population Description

Not all participants completed the assessment

Arm/Group Title	Tobacco Status Project + Alcohol Intervention	Tobacco Status Project Intervention
Arm/Group Description	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	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
Measure Participants	78	89
Month 3	48 56.5%	63 67%
Month 6	36 42.4%	49 52.1%
Month 12	43 50.6%	52 55.3%

Adverse Events

Time Frame	Up to 1 year
Adverse Event Reporting Description	Non-serious adverse events were not collected
Arm/Group Title	Tobacco Status Project + Alcohol Intervention		Tobacco Status Project Intervention
Arm/Group Description	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		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
All Cause Mortality
	Tobacco Status Project + Alcohol Intervention		Tobacco Status Project Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/85 (0%)		0/94 (0%)
Serious Adverse Events
	Tobacco Status Project + Alcohol Intervention		Tobacco Status Project Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/85 (0%)		0/94 (0%)
Other (Not Including Serious) Adverse Events
	Tobacco Status Project + Alcohol Intervention		Tobacco Status Project Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Self-reported vaping frequency may have impacted biochemically verified nicotine abstinence validity

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.