Cigarette Pack Inserts for Smoking Cessation

Study Overview
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Brief Summary
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This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit. To do this, the investigators will conduct a 2 X 2 between-subject experiment in which 380 smokers will be randomized into one of four labeling groups: 1. no inserts or pictorial health warning labels (HWLs); 2. inserts only; 3. pictorial HWLs only; 4. inserts & pictorial HWLs. Smokers will be given a 14-day supply of their preferred cigarette brand with packs labeled according to their experimental group. Participants will answer a brief survey at the end of each day and four other times each day, using ecological momentary assessment approaches. The investigators will study whether smokers in each group experience different psychological responses and behaviors associated with smoking cessation.

Official Title
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Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Inserts with efficacy messages
* Other: Pictorial warnings on packs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 or older Have smoked at least 100 cigarettes in their lifetime Smoked at least 10 cigarettes a day in the prior month. Exclusion Criteria: Use of other nicotine products besides cigarettes in the prior month. Pregnant women

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: In a 2 X 2 between subject design, smokers will be randomized into one of four cigarette package labeling conditions: 1. no inserts or pictorial HWLs; 2. inserts only; 3. pictorial HWLs only; 4. inserts & pictorial HWLs
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard cigarette packs (control)<br>Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with the only alteration being the small health warning message on the side of the pack, whose textual content will be the same as that used for the pictorial warning label conditions. | |
| Experimental: Cigarette packs with inserts only<br>Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four different rotating messages to promote response efficacy beliefs (2 inserts on the benefits of cessation) or self-efficacy to quit (2 inserts with cessation tips). | Other: Inserts with efficacy messages<br>* Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.<br>|
| Experimental: Cigarette packs with pictorial warnings only<br>Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include four different rotating pictorial warnings showing the consequences of smoking and that cover 50% of the front and back of the pack. | Other: Pictorial warnings on packs<br>* Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.<br>|
| Experimental: Cigarette packs with inserts and pictorial warnings<br>Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four rotating efficacy messages (see description above) and four rotating pictorial warnings (see above). | Other: Inserts with efficacy messages<br>* Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.<br>Other: Pictorial warnings on packs<br>* Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy to quit smoking | A single question measured on a continuous scale (1=Not at all, worse outcome; 7=Extremely, better outcome) to assess strength of confidence to quit smoking | Evaluated approximately 4 times a day over the 14 day study period | 
| Worry about harms from smoking | A single question measured on a continuous scale to assess strength of worry about harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome) | Evaluated approximately 4 times a day over the 14 day study period | 
| Strength of feeling about smoking | A single questions measured on a continuous scale to assess strength of positive to negative feelings about smoking (1=very BAD, good outcome; 7=very GOOD, worse outcome) | Evaluated approximately 4 times a day over the 14 day study period | 
| Extent of motivation to quit smoking | A single question measured on a continuous scale to assess the extent of motivation to quit smoking (1=Not at all, worse outcome; 7=Extremely, better outcome) | Evaluated approximately 4 times a day over the 14 day study period | 
| Talk about smoking cessation | A single question to count the number of times the participant talked about smoking cessation or smoking-related harms in the prior 24 hours or the study period (depending on the analysis) | Evaluated once each day (evening report) over the 14 day study period | 
| Foregoing a cigarette | Two questions combined to count whether the participant a) did not smoking a cigarette when they normally would or b) stubbed out a cigarette earlier than normal in the prior 24 hours or the study period (depending on the analysis) | Evaluated once each day (evening report) over the 14 day study period | 
| Self-efficacy to cut down on smoking | A single question measured on a continuous scale (1=Not at all, worse outcome; 7=Extremely, better outcome) to assess strength of confidence to cut down on the number of cigarettes smoked | Evaluated approximately 4 times a day over the 14 day study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength of hopefulness about quitting | A single question measured on a continuous scale to assess strength of feeling hopeful about quitting (1=Not at all, worse outcome; 7=Extremely, better outcome) | Evaluated approximately 4 times a day over the 14 day study period | 
| Extent of cognitive elaboration of smoking benefits | A single question measured on a continuous scale to assess the frequency of thinking about the positive things about smoking (1=Not at all, better outcome; 7=Extremely, worse outcome) | Evaluated once each day (evening report) over the 14 day study period | 
| Extent of cognitive elaboration of smoking harms | A single question measured on a continuous scale to assess the frequency of thinking about the harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome) | Evaluated once each day (evening report) over the 14 day study period | 
| Extent of cognitive elaboration of cessation benefits | A single question measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1=Not at all, worse outcome; 7=Extremely, better outcome) | Evaluated once each day (evening report) over the 14uestion measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1=Not at all, worse outcome; 7=Extre day study period | 
| Strength of beliefs about benefits of smoking cessation (i.e., response efficacy) | A single question measured on a continuous scale to assess the strength of perceived benefits from cessation (1=Not at all, worse outcome; 7=Extremely, better outcome) | Evaluated once each day (evening report) over the 14 day study period | 
| Strength of perceived susceptibility to smoking harms | A single question measured on a continuous scale to assess the perceived likelihood of suffering harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome) | Evaluated once each day (evening report) over the 14 day study period | 
| Expressed reactance against health messages | Binary measure of talking about how health information on packs is useless or not believable in the prior 24 hours or over the study period (depending on the analysis) | Evaluated once each day (evening report) over the 14 day study period | 
| Cigarettes per day | Continuous variable for the number of cigarettes smoked each day | Evaluated each day over the 14 day study period, using daily reports and participant logging of cigarettes | 
| Satisfaction from smoking | Single question measured on a continuous scale that assesses strength of satisfaction from smoking (1=Not at all, better outcome; 7=Extremely, worse outcome) | Evaluated approximately 4 times a day over the 14 day study period |