Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers

Tobacco Use Clinical Trial

Official title:

Examining the Impact of Cigarette Package Warnings and Packaging Regulations Among Young Adult Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446170
• Other study ID #: 2014-1031
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: August 31, 2020

Study information

• Verified date: December 2021
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Exclusion Criteria:

• No additional exclusion criteria

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. 2021 Sep 23. doi: 10.1007/s10865-021-00258-2. [Epub ahead of print] — View Citation

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. 2021 Aug 20. pii: kaab073. doi: 10.1093/abm/kaab073. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette purchase appeal	The effects of graphic cigarette warnings and plain packaging on cigarette purchase appeal will be measured using data collected from a within-subjects experiment at baseline. Participants are randomly assigned to compare each pair of packs from the experimental conditions versus a standard branded control pack. For each pair, cigarette purchase appeal is measured with 5 valid questions assessing: 1) Which pack would you be most likely to buy? 2) Which pack is the most appealing? 3) Which pack attracts your attention? 4) Which pack contains cigarettes that are the most harmful to your health? 5) Which pack makes you think about the health risks of smoking?	Baseline
Primary	Motivation to quit smoking	Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.	At the conclusion of the 4 week exposure
Secondary	Cigarette smoking behavior	Cigarettes smoked per day is measured using a single valid question assessing about how many cigarettes participants smoked each day, on average.	At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Secondary	Smoking quit attempts	Attempts to quit smoking is measured using a single valid item asking participants how many times they stopped smoking for 1 day or longer because they were trying to quit.	At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Secondary	Motivation to quit cigarette smoking.	Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.	At 1-month and 3-months post-exposure