Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors

NCT02301351 | Completed

• 2 other identifiers: 819610P50CA179546
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking Behavior

Outcome Measures

Primary Outcomes (1)

• Daily Cigarette Rate (smoking behavior)

  Daily cigarette consumption will be determined by the difference of unused cigarettes and used cigarette filters returned to the Center every Session after Day 0.The number of used cigarette filters and self-reported daily smoking rate will be recorded on a Smoking Rate Data Collection Form. We will examine changes in daily cigarette consumption averaged over each of the three 15-day pack periods.

  Days 0-50

Secondary Outcomes (5)

• Smoking Topography

  Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50

• Subjective Cigarette Ratings

  Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50

• Carbon Monoxide (CO)

  Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50

• Attitudes and Intentions (to use product)

  Days 0, 5, 20, 35, & 50

• Cigarette Risk Beliefs

  Days 0, 5, 20, 35, & 50

Study Arms (2)

Graphic Warning Label

OTHER

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.

Other: Graphic Warning Label

Text Warning Label

OTHER

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.

Other: Text Warning Label

Interventions

Graphic Warning Label OTHER

All packs provided will include FDA-approved graphic warning labels

Graphic Warning Label

Text Warning Label OTHER

All packs provided will include standard text warning labels

Text Warning Label

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Food and Drug Administration (FDA): collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 37891513 DERIVED

• 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.

  PMID: 32994296 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Andrew Strasser, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 12, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)