Cigarette Pack Inserts for Smoking Cessation

NCT04075682 | Completed Results

• 1 other identifier: Pro00083728
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (9)

• Strength of Hopefulness About Quitting

  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

  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

  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

  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)

  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 Outcomes (2)

• Conversation Partners

  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

  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.

Study Arms (4)

Standard cigarette packs (control)

NO INTERVENTION

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.

Cigarette packs with inserts only

EXPERIMENTAL

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

Cigarette packs with pictorial warnings only

EXPERIMENTAL

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

Cigarette packs with inserts and pictorial warnings

EXPERIMENTAL

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; Other: Pictorial warnings on packs

Interventions

Inserts with efficacy messages OTHER

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.

Cigarette packs with inserts and pictorial warnings; Cigarette packs with inserts only

Pictorial warnings on packs OTHER

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.

Cigarette packs with inserts and pictorial warnings; Cigarette packs with pictorial warnings only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• Have smoked at least 100 cigarettes in their lifetime
• Smoked at least 10 cigarettes a day in the prior month.

You may not qualify if:

• Use of other nicotine products besides cigarettes in the prior month.
• Pregnant women

Sponsors & Collaborators

• University of South Carolina: lead
• Cornell University: collaborator
• University of Waterloo: collaborator
• University of Tasmania: collaborator

Study Sites (2)

Cornell University

Ithaca, New York, 14853, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Dr. James F. Thrasher
• Organization: University of South Carolina

thrasher@sc.edu

803.777.4862

Study Officials

• James F Thrasher, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: September 3, 2019
• Study Start: August 1, 2019
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: May 13, 2024
• Results First Posted: May 13, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)