Cigarette Pack Inserts for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075682
• Other study ID #: Pro00083728
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 29, 2021

Study information

• Verified date: November 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina
United States	Cornell University	Ithaca	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of South Carolina	Cornell University, University of Tasmania, University of Waterloo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).