NCT03446170

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

6 years

First QC Date

February 12, 2018

Last Update Submit

December 14, 2021

Conditions

Keywords

Young adultsCigarette smokingWarning labels

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Cigarette smoking behavior

    At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure

  • Smoking quit attempts

    At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure

  • Motivation to quit cigarette smoking.

    At 1-month and 3-months post-exposure

Study Arms (5)

Loss-framed, branded

EXPERIMENTAL

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

Behavioral: Graphic cigarette warning labels, plain packaging

Loss-framed, plain

EXPERIMENTAL

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

Behavioral: Graphic cigarette warning labels, plain packaging

Gain-framed, branded

EXPERIMENTAL

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

Behavioral: Graphic cigarette warning labels, plain packaging

Gain-framed, plain

EXPERIMENTAL

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

Behavioral: Graphic cigarette warning labels, plain packaging

Control

NO INTERVENTION

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

Interventions

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

Gain-framed, brandedGain-framed, plainLoss-framed, brandedLoss-framed, plain

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related 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.

    PMID: 33895661BACKGROUND
  • 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.

    PMID: 34415010BACKGROUND
  • 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.

    PMID: 34554369BACKGROUND

MeSH Terms

Conditions

Tobacco UseCigarette Smoking

Condition Hierarchy (Ancestors)

BehaviorTobacco SmokingSmoking

Study Officials

  • Darren Mays, PhD, MPH

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The study tests the effects of graphic cigarette warning labels and packaging regulations, therefore it is unmasked.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 26, 2018

Study Start

September 1, 2014

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations