Clinical trial NCT02301351: Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors
Official title: Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking Behavior
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2014-11-25
Enrollment: 316
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Daily Cigarette Rate (smoking behavior)
timeFrame: Days 0-50
Secondary outcomes:
measure: Smoking Topography
timeFrame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
measure: Subjective Cigarette Ratings
timeFrame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
measure: Carbon Monoxide (CO)
timeFrame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
measure: Attitudes and Intentions (to use product)
timeFrame: Days 0, 5, 20, 35, & 50
measure: Cigarette Risk Beliefs
timeFrame: Days 0, 5, 20, 35, & 50
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew Strasser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.