Cigarette Pack Inserts for Smoking Cessation

Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Inserts with efficacy messages; Other: Pictorial warnings on packs

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14853
      • Cornell University
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard cigarette packs (control); 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; 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; 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.
Experimental: Cigarette packs with pictorial warnings only; 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; 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.
Experimental: Cigarette packs with inserts and pictorial warnings; 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; 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.; Other: Pictorial warnings on packs; 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.

What is the study measuring?

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, with average scores (range 1-7) estimated.	Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
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, with average scores (range=1-7) estimated.	Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
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), with average scores (range=1-7) estimated.	Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Strength of Feeling About Smoking	A single question measured on a continuous scale to assess strength of positive to negative feelings about smoking (1="very bad", better outcome; 7="very good", worse outcome), with average scores (range=1-7) estimated	Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
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), with average scores (range=1-7) estimated.	Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Talk About Smoking Cessation	For each day, a single binary variable was derived to indicate whether the participant talked about either smoking cessation or smoking-related harms in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event of talking about cessation or harms is a better outcome, as it is a predictor of cessation attempts.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Foregoing a Cigarette	For each day, responses to two questions were combined to create a binary variable for whether, in the prior 24 hours, the participant a) did not smoke a cigarette when they normally would, and/or b) stubbed out a cigarette before finishing it, with the average daily percentage of this outcome estimated. Experiencing the event of forgoing/stubbing out is a better outcome, as it is a predictor of cessation attempts.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.

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), with average scores (range 1-7) estimated.	Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
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), with average scores (range 1-7) estimated.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
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), with average scores (range 1-7) estimated.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
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), with average scores (range 1-7) estimated.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
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), with average scores (range 1-7) estimated.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
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), with average scores (range 1-7) estimated.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Expressed Reactance Against Health Messages	a. Binary measure for whether the participant reported talking about how health information on packs is either useless or not believable in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event is a worse outcome, as it suggests defensive responding to labels.	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
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), with average scores (range 1-7) estimated.	Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Cigarettes Logged	Continuous variable summing the total number of cigarettes logged over the study period. Lower values represent a better outcome (i.e., fewer cigarettes smoked).	Participants logged each cigarette smoked over the 14 day study period, with analyses limited to reports from days 2-14. Day 1 and 15 were dropped due to varying coverage of the day depending on study orientation time (Day 1) and ending (Day 15).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversation Partners	Nominal variable indicating the types of people with whom people talked about smoking and cessation in the prior 24 hours	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Conversation Topics	Nominal variable indicating the topics of conversation around smoking in the prior 24 hours	Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Cornell University; University of Waterloo; University of Tasmania
• Investigators: Principal Investigator: James F Thrasher, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): June 29, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pro00083728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are likely to make participant data to researchers who make specific requests and have specific data analysis plans that we approve.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No