Smoking Tobacco and Drinking Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using Facebook to Address Smoking and Heavy Drinking in Young Adults

Conditions
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Smoking, Heavy Episodic Drinking

Intervention / Treatment
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* Behavioral: Tobacco Status Project Intervention
* Behavioral: Tobacco Status Project + Alcohol Intervention
* Drug: nicotine patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Cigarettes, Alcohol, Cessation, Intervention, Young adults, Internet, Social media