Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers

NCT ID: NCT03446170

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2020-08-31

Brief Summary

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The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.

Detailed Description

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The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.

Conditions

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Tobacco Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The experimental design is a 2 (graphic warning message framing: gain versus loss) by 2 (cigarette packaging: standardized, plain or branded) factorial design. An unexposed control group is also included.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The study tests the effects of graphic cigarette warning labels and packaging regulations, therefore it is unmasked.

Study Groups

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Loss-framed, branded

Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on branded packages.

Group Type EXPERIMENTAL

Graphic cigarette warning labels, plain packaging

Intervention Type BEHAVIORAL

This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging

Loss-framed, plain

Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on plain or standardized packages.

Group Type EXPERIMENTAL

Graphic cigarette warning labels, plain packaging

Intervention Type BEHAVIORAL

This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging

Gain-framed, branded

Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on branded packages.

Group Type EXPERIMENTAL

Graphic cigarette warning labels, plain packaging

Intervention Type BEHAVIORAL

This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging

Gain-framed, plain

Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on plain or standardized packages.

Group Type EXPERIMENTAL

Graphic cigarette warning labels, plain packaging

Intervention Type BEHAVIORAL

This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging

Control

Participants assigned to this arm use their regular cigarette packs and complete study measures only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Graphic cigarette warning labels, plain packaging

This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Ages 18 to 30 years
* Smoke at least 100 cigarettes in their lifetime
* Now smoke cigarettes on all or some days
* Reside in the Washington, DC metro area
* Willing to send and receive text messages on a personal mobile phone
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Darren Mays

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darren Mays, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Johnson AC, Luta G, Tercyak KP, Niaura RS, Mays D. Effects of pictorial warning label message framing and standardized packaging on cigarette packaging appeal among young adult smokers. Addict Behav. 2021 Sep;120:106951. doi: 10.1016/j.addbeh.2021.106951. Epub 2021 Apr 13.

Reference Type BACKGROUND
PMID: 33895661 (View on PubMed)

Johnson AC, Turner MM, Simmens SJ, Evans WD, Strasser AA, Mays D. Mediational Effects on Motivation to Quit Smoking After Exposure to a Cigarette Pictorial Warning Label Among Young Adults. Ann Behav Med. 2022 Jul 12;56(7):737-748. doi: 10.1093/abm/kaab073.

Reference Type BACKGROUND
PMID: 34415010 (View on PubMed)

Johnson AC, Simmens SJ, Turner MM, Evans WD, Strasser AA, Mays D. Longitudinal effects of cigarette pictorial warning labels among young adults. J Behav Med. 2022 Feb;45(1):124-132. doi: 10.1007/s10865-021-00258-2. Epub 2021 Sep 23.

Reference Type BACKGROUND
PMID: 34554369 (View on PubMed)

Other Identifiers

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2014-1031

Identifier Type: -

Identifier Source: org_study_id

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