A Smoking Cessation Intervention for Yale Dining Employees

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a smoking cessation program for employees at the Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3 control sites) will be offered a contingency management/pharmacotherapy smoking cessation intervention at the work site.

Detailed Description
-----------------
The primary aim of this study is to test the effect of a smoking cessation intervention provided to Yale University dining hall employees on smoking quit rates and quit attempts at the end of six weeks of treatment. It is hypothesized that participants from the test site will have higher rates of smoking cessation and quit attempts compared to participants from the control site. In addition, this study will examine the number of participants who enroll in the smoking cessation program who successfully quit smoking at 6 months. There will be 3 test sites and 3 control sites in this study (broken down into 3 pairs of test/control). Each test site will be matched to on a control site. Self-reported smoking status will be obtained for all participants in the test and control sites at 3 time points (baseline, 6 weeks and 6 months). The study start time for each pair will be delayed by 4-8 weeks for feasibility issues.

Official Title
-----------------
A Smoking Cessation Intervention for Yale Dining Employees

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Contingency management
* Drug: Nicotine replacement therapy
* Drug: Varenicline
* Behavioral: Additional behavioral support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smoker Interested in receiving treatment for quitting smoking. Employed for more than 20 hours per week by one of the 7 residential college dining halls selected for inclusion in this study. English speaker. Exclusion Criteria: None specified, other than failure to meet all inclusion criteria listed above.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking Cessation Treatment<br>The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting. | Behavioral: Contingency management<br>* Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.<br>Drug: Nicotine replacement therapy<br>* Participants have the option of using nicotine patch in combination with nicotine gum or lozenge<br>Drug: Varenicline<br>* Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative<br>Behavioral: Additional behavioral support<br>* Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support<br>* Other names: telephone quit lines and mobile applications;|
| No Intervention: Delayed Treatment Control<br>Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks | A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt. | 6 weeks | 
| Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks | A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Quit Smoking at 2 Months | Smoking cessation is operationally defined as successfully quitting smoking at 2 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). | Month 2 | 
| Number of Participants Who Quit Smoking at 3 Months | Smoking cessation is operationally defined as successfully quitting smoking at 3 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). | Month 3 | 
| Number of People Who Quit Smoking at 4 Months | Smoking cessation is operationally defined as successfully quitting smoking at 4 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). | Month 4 | 
| Number of People Who Quit Smoking at 5 Months | Smoking cessation is operationally defined as successfully quitting smoking at 5 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). | Month 5 | 
| Number of People Who Quit Smoking at 6 Months | Smoking cessation is operationally defined as successfully quitting smoking at 6 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). | Month 6 | 
| Wisconsin Predicting Patient's Relapse Questionnaire | Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse. | Baseline | 
| Wisconsin Predicting Patient's Relapse Questionnaire | Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse. | Month 6 |