Cigarette Pack Inserts for Smoking Cessation

NCT ID: NCT04075682

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-06-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Inserts with efficacy messages

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Pictorial warnings on packs

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Inserts with efficacy messages

Intervention Type: 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.

Pictorial warnings on packs

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: collaborator

University of Tasmania

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

James Francis Thrasher, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James F Thrasher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

Cornell University

Ithaca, New York, United States

University of South Carolina

Columbia, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00083728

Identifier Type: -

Identifier Source: org_study_id