Impact of Cigarette Pack Constituent Disclosures

NCT02785484 | Completed DMC

• 2 other identifiers: 12-2430P50CA180907
• Study Type: interventional
• Target: 784
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cigarette smoking; Smoking; Tobacco use

Outcome Measures

Primary Outcomes (1)

• Quit intentions

  The primary outcome is quit intentions measured at 4 weeks by survey.

  4 weeks

Secondary Outcomes (9)

• Awareness of health effects from smoking cigarettes

  4 weeks

• Awareness of cigarette smoke constituents

  4 weeks

• Quit attempts

  Up to 4 weeks

• Successful Quitting

  4 weeks

• Forgoing a cigarette

  4 weeks

Study Arms (2)

Label with constituent disclosure message

EXPERIMENTAL

Other: Label with constituent disclosure message

Label with litter message

OTHER

Other: Label with litter message

Interventions

Label with constituent disclosure message OTHER

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.

Label with constituent disclosure message

Label with litter message OTHER

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.

Label with litter message

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 21 years or older
• Have smoked at least 100 cigarettes in his or her lifetime
• Currently smoke cigarettes every day or some days
• Currently smoke at least 7 cigarettes per week, on average
• Be able to read and speak English
• Be able to use a computer to take surveys
• Be able to attend 5 weekly appointments
• Be able to bring in 8 days' worth of cigarettes to each of the first 4 weekly appointments

You may not qualify if:

• Smokers who smoke exclusively roll-your-own cigarettes
• Pregnant women
• Smokers concurrently enrolled in any research studies about smoking or using other tobacco products
• Smokers who live in the same household as someone who has enrolled in the study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Cancer Institute (NCI): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Ewald & Wasserman Research Consultants, LLC

San Francisco, California, 94108, United States

Location

Related Publications (1)

• Brewer NT, Jeong M, Mendel JR, Hall MG, Zhang D, Parada H Jr, Boynton MH, Noar SM, Baig SA, Morgan JC, Ribisl KM. Cigarette pack messages about toxic chemicals: a randomised clinical trial. Tob Control. 2019 Jan;28(1):74-80. doi: 10.1136/tobaccocontrol-2017-054112. Epub 2018 Apr 13.

  PMID: 29654122 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Tobacco Use

Interventions

Drug Labeling

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Packaging; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Study Officials

• Noel Brewer, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: May 27, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)