Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors

NCT ID: NCT02301351

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-04-12

Brief Summary

The purpose of this study is to examine the effect of changes in cigarette package color and warning label features on smoking behaviors and beliefs about cigarette risks.

Detailed Description

This project will recruit 360, current daily Marlboro, non-menthol, red (n=180) or gold (n=180) cigarette smokers to a 50-day protocol using a randomized factorial design with two factors: (1) cigarette pack color manipulation (within subject: red, gold, plain packaging) and (2) warning label manipulation (between subject: graphic vs. standard text). The randomization will be stratified by own brand cigarette. To evaluate effects of changes in cigarette package coloring, participants will smoke commercially available cigarettes that may or may not be similar to their preferred brand of cigarettes throughout the study, but in different colored packages during three 15-day study periods (i.e., one period will be Marlboro plain (tan-olive) packs, one will be Marlboro gold packs and one will be Marlboro red packs; order counterbalanced). Participants will visit the Center every 5 days to complete assessments (11 total sessions).

Conditions

Cigarette Smoking Behavior

Study Design

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

Study Groups

Graphic Warning Label

Days 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with FDA-approved graphic warning labels.

Group Type: OTHER

Graphic Warning Label

Intervention Type: OTHER

All packs provided will include FDA-approved graphic warning labels

Text Warning Label

Days 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with standard text warning labels.

Group Type: OTHER

Text Warning Label

Intervention Type: OTHER

All packs provided will include standard text warning labels

Interventions

Graphic Warning Label

All packs provided will include FDA-approved graphic warning labels

Intervention Type: OTHER

Text Warning Label

All packs provided will include standard text warning labels

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months.
• Smokers of primarily non-menthol, Marlboro red or gold type cigarettes.
• Not using any forms of nicotine other than cigarettes.
• Not currently undergoing smoking cessation treatment or tying to quit.
• Able to communicate fluently in English (speaking, writing, and reading).
• Plan to remain in the area over the duration of the trial.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

Exclusion Criteria

Smoking Behavior.

• Use of any nicotine products other than cigarettes.
• Enrollment or plans to enroll in a smoking cessation program over the duration of the trial.
• Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Day 0.

Alcohol/Drugs.

• History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Provide a breath alcohol concentration (BrAC) reading greater than .000 at Day 0.

Medical.

• Women who are pregnant, planning a pregnancy, and/or lactating.
• Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.
• Color blindness.
• Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.

Psychiatric.

• Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
• Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible.

Other.

• Any medical condition, extenuating circumstance, illness, disorder, adverse event (AE), and/or concomitant medication that could compromise participant safety and/or completion of the study procedures, as determined by the Principal Investigator. Subjects may be deemed ineligible or withdrawn for any of the aforementioned reasons at any point throughout the study.
• Non-compliance with the protocol and/or study design as determined by the Principal Investigator.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Andrew Strasser

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Strasser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Stone MD, Mercincavage M, Wileyto EP, Tan ASL, Audrain-McGovern J, Villanti AC, Strasser AA. Effects of cigarette package colors and warning labels on marlboro smokers' risk beliefs, product appraisals, and smoking behavior: a randomized trial. BMC Public Health. 2023 Oct 27;23(1):2111. doi: 10.1186/s12889-023-17024-5.

Reference Type: DERIVED

PMID: 37891513 (View on PubMed)

Mercincavage M, Albelda B, Mays D, Souprountchouk V, Giovenco DP, Audrain-McGovern J, Strasser AA. Shedding 'light' on cigarette pack design: colour differences in product perceptions, use and exposure following the US descriptor ban. Tob Control. 2022 Jan;31(1):19-24. doi: 10.1136/tobaccocontrol-2020-055886. Epub 2020 Sep 29.

Reference Type: DERIVED

PMID: 32994296 (View on PubMed)

Other Identifiers

P50CA179546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

819610

Identifier Type: -

Identifier Source: org_study_id