Impact of Cigarette Pack Constituent Disclosures

Summary

The purpose of this randomized controlled trial is to determine whether constituent disclosures on cigarette packs increase intentions to quit smoking. Previous studies have been informative, but they have evaluated candidate graphic warnings, not constituent disclosures. Furthermore, they typically expose participants to messages in controlled but artificial experimental settings for a short period of time, using much lower frequency and shorter duration of message exposure than found in the real world. This study addresses these issues by evaluating the impact of constituent disclosures by randomly assigning smokers to have their cigarette packs labeled with constituent disclosure messages or cigarette butt littering messages.

Conditions

• Cigarette Smoking Behavior

Interventions

OTHER

Label with constituent disclosure message

Labels with constituent disclosure messages that include text about chemicals in cigarette smoke and health effects of the chemicals will be applied to participants' cigarette packs on the right side (the Surgeon General's warning is on the left side). At the week 2 visit, participants' packs will be labeled with 1 of 3 disclosures selected at random; at the week 3 visit, they will get one of the 2 remaining disclosures selected at random, and at the week 4 visit they will get the remaining disclosure. Study investigators developed the text and design of these labels.

OTHER

Label with litter message

Labels with litter messages that include text about littering cigarette butts will be applied to participants' cigarette packs on the right side (the Surgeon General's warning is on the left side). At the week 2 visit, participants' packs will be labeled with 1 of 3 litter messages selected at random; at the week 3 visit, they will get one of the 2 remaining litter message selected at random, and at the week 4 visit they will get the remaining litter message. Study investigators developed the text and design of these labels.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Food and Drug Administration (FDA)

  collaborator FED

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Noel Brewer, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2017-03-31

Completion

2017-03-31

Countries

• United States

Study Locations