Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers

Georgetown University

Status: Completed

Conditions: Tobacco Use

Treatments: Behavioral: Graphic cigarette warning labels, plain packaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03446170

2014-1031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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400 participants in 5 patient groups

Loss-framed, branded

Experimental group

Description:

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

Treatment:

Behavioral: Graphic cigarette warning labels, plain packaging

Loss-framed, plain

Experimental group

Description:

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

Treatment:

Behavioral: Graphic cigarette warning labels, plain packaging

Gain-framed, branded

Experimental group

Description:

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

Treatment:

Behavioral: Graphic cigarette warning labels, plain packaging

Gain-framed, plain

Experimental group

Description:

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

Treatment:

Behavioral: Graphic cigarette warning labels, plain packaging

Control

No Intervention group

Description:

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