Trial Outcomes & Findings for Smoking Tobacco and Drinking Study (NCT NCT03163303)

Last Updated: 2020-08-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

179 participants

Primary outcome timeframe

3 months post baseline

Results posted on

2020-08-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	85	94
Overall Study COMPLETED	85	94
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smoking Tobacco and Drinking Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tobacco Status Project + Alcohol Intervention n=85 Participants 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 Status Project Intervention n=94 Participants 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 n=179 Participants Total of all reporting groups
Age, Continuous	22.1 years STANDARD_DEVIATION 2.32 • n=5 Participants	22.1 years STANDARD_DEVIATION 2.08 • n=7 Participants	22.1 years STANDARD_DEVIATION 2.20 • n=5 Participants
Sex/Gender, Customized Female	33 Participants n=5 Participants	49 Participants n=7 Participants	82 Participants n=5 Participants
Sex/Gender, Customized Male	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Sex/Gender, Customized Transgender or non-binary	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	92 Participants n=7 Participants	171 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	78 Participants n=7 Participants	144 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants	94 participants n=7 Participants	179 participants n=5 Participants
Geographic region South	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Geographic region West	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Geographic region Midwest	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Geographic region Northeast	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Number of Cigarettes Smoked in Past 7 days	76.2 number of cigarettes STANDARD_DEVIATION 60.9 • n=5 Participants	68.6 number of cigarettes STANDARD_DEVIATION 44.7 • n=7 Participants	72.6 number of cigarettes STANDARD_DEVIATION 53.8 • n=5 Participants
Usual Number of Cigarettes per Day	10.1 cigarettes per day STANDARD_DEVIATION 6.23 • n=5 Participants	10.8 cigarettes per day STANDARD_DEVIATION 7.35 • n=7 Participants	10.4 cigarettes per day STANDARD_DEVIATION 6.9 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months post baseline

Population: Not all participants completed the Month 3 assessment

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=69 Participants 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 Status Project Intervention n=79 Participants 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
Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months	3 Participants	4 Participants

PRIMARY outcome

Timeframe: 6 months post baseline

Population: Not all participants completed the Month 6 assessment

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

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=53 Participants 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 Status Project Intervention n=61 Participants 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
Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 12 months post baseline

Population: Not all participants completed the Month 12 assessment

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

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=70 Participants 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 Status Project Intervention n=81 Participants 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
Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 3, 6, and 12 months post baseline

Population: Not all participants completed the assessment

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

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Number of Participants With a Reduction in Cigarettes Smoked Over Time Month 3	32 Participants	35 Participants
Number of Participants With a Reduction in Cigarettes Smoked Over Time Month 6	35 Participants	30 Participants
Number of Participants With a Reduction in Cigarettes Smoked Over Time Month 12	46 Participants	46 Participants

SECONDARY outcome

Timeframe: 3, 6, and 12 month post-baseline

Population: Not all participants complete the assessment

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.

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment	49 Participants	45 Participants

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Not all participants completed the assessment

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

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time Month 3	37 Participants	27 Participants
Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time Month 6	20 Participants	23 Participants
Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time Month 12	34 Participants	41 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=85 Participants 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 Status Project Intervention n=94 Participants 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
Average Score on the Thoughts About Abstinence Questionnaire (Smoking) Desire to quit	6.1 score on a scale Standard Deviation 2.6	5.9 score on a scale Standard Deviation 2.5
Average Score on the Thoughts About Abstinence Questionnaire (Smoking) Expected success	4.6 score on a scale Standard Deviation 2.3	5.1 score on a scale Standard Deviation 2.6
Average Score on the Thoughts About Abstinence Questionnaire (Smoking) Expected difficulty	7.2 score on a scale Standard Deviation 2.4	7.1 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Not all participants completed the assessment

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.

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Average Number of Days of Heavy Episodic Drinking (HED) Over Time Month 3	4.8 days Standard Deviation 7	7.6 days Standard Deviation 8.2
Average Number of Days of Heavy Episodic Drinking (HED) Over Time Month 6	3.8 days Standard Deviation 5.5	6 days Standard Deviation 7.8
Average Number of Days of Heavy Episodic Drinking (HED) Over Time Month 12	3.2 days Standard Deviation 5.2	5.6 days Standard Deviation 7.6

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Not all participants completed the assessment

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.

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Median Number of Drinks Per Week Over Time Month 6	5 drinks per week Interval 0.0 to 11.0	7 drinks per week Interval 0.0 to 15.0
Median Number of Drinks Per Week Over Time Month 12	1 drinks per week Interval 0.0 to 7.8	4 drinks per week Interval 0.0 to 16.0
Median Number of Drinks Per Week Over Time Month 3	4 drinks per week Interval 0.0 to 12.0	6 drinks per week Interval 0.0 to 17.0

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Not all participants completed the assessment

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.

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time Month 3	3.9 score on a scale Standard Deviation 2.7	5 score on a scale Standard Deviation 2.9
Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time Month 6	3.7 score on a scale Standard Deviation 2.7	4.8 score on a scale Standard Deviation 3
Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time Month 12	3.4 score on a scale Standard Deviation 2.4	4.1 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Not all participants completed the assessment

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

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Readiness to Change Alcohol Use Over Time Month 3	40 Participants	42 Participants
Readiness to Change Alcohol Use Over Time Month 6	28 Participants	38 Participants
Readiness to Change Alcohol Use Over Time Month 12	42 Participants	54 Participants

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Data not collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, and 12 months post-baseline

Population: Not all participants completed the assessment

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

Outcome measures

Outcome measures
Measure	Tobacco Status Project + Alcohol Intervention n=78 Participants 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 Status Project Intervention n=89 Participants 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
Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time Month 3	48 Participants	63 Participants
Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time Month 6	36 Participants	49 Participants
Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time Month 12	43 Participants	52 Participants

Adverse Events

Tobacco Status Project + Alcohol Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tobacco Status Project Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Derek Satre

University of California, San Francisco

Phone: (415) 476-7382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place