Smoking Tobacco and Drinking Study

Phase 4

Completed

• Conditions: Smoking; Heavy Episodic Drinking
• Interventions: Behavioral: Tobacco Status Project + Alcohol Intervention; Behavioral: Tobacco Status Project Intervention; Drug: nicotine patch

• Registration Number: NCT03163303
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-23
• Study Start: 2017-12-18
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Results First Submitted: 2020-07-01
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-10
• Last Update Submitted: 2020-08-10
• Results First Posted: 2020-08-12
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobacco Status Project (TSP) + Alcohol Intervention	Tobacco Status Project + Alcohol Intervention	Tobacco and alcohol intervention on Facebook and 14-day nicotine patch
Tobacco Status Project Intervention	Tobacco Status Project Intervention	Tobacco intervention on Facebook and 14-day nicotine patch
Tobacco Status Project (TSP) + Alcohol Intervention	nicotine patch	Tobacco and alcohol intervention on Facebook and 14-day nicotine patch
Tobacco Status Project Intervention	nicotine patch	Tobacco intervention on Facebook and 14-day nicotine patch

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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
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.
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.
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
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
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.
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
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.

Trial Locations

Locations (1)

University of California San Francisco Department of Psychiatry; 🇺🇸 San Francisco, California, United States