Impact of Graphic Cigarette Warnings

NCT02247908 | Completed DMC

• 2 other identifiers: 13-28613P30CA016086-38S2
• Study Type: interventional
• Target: 2,149
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this randomized controlled trial is to determine whether graphic health warnings on cigarette packs are more effective than the existing Surgeon General's warning on cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate graphic warnings have been informative, they have used psychological outcomes, such as attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts). Furthermore, they typically expose participants to warnings in controlled but artificial experimental settings for a short period of time, using much lower frequency and shorter duration of warning exposure than found in the real world. This study addresses these issues by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have their cigarette packs labeled with either a graphic warning or a Surgeon General's warning for four weeks. Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized to receive a Surgeon General's label on their cigarette packs. Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon General's label on their cigarette packs, controlling for baseline quit intentions.

Conditions

Smoking

Keywords

Cigarette smoking; Smoke; Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Quit attempts

  The primary outcome is a quit attempt during the 4 weeks of the study, reported at either 1, 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.

  Up to 4 weeks

Secondary Outcomes (9)

• Change in quit intentions

  4 weeks

• Successful Quitting

  4 weeks

• Change in forgoing a cigarette

  4 weeks

• Change in positive reinforcement attitudes

  4 weeks

• Change in negative reinforcement attitudes

  4 weeks

Other Outcomes (27)

• Change in smoking quantity

  4 weeks

• Change in cessation aid use

  4 weeks

• Change in e-cigarette use frequency

  4 weeks

Study Arms (2)

Graphic Warning

EXPERIMENTAL

Graphic warnings that include text and an image depicting a health effect of smoking will be applied on labels that cover the top half of the front and back of participants' cigarette packs each week for 4 weeks. Within the graphic warning condition, participants will be assigned to receive 1 of 4 warnings for 4 weeks. The text for these warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA.

Other: Graphic Warning

Surgeon General's Warning

ACTIVE COMPARATOR

Labels with Surgeon General's Warning text will be applied to the side of participants' cigarette packs each week for 4 weeks, on top of the Surgeon General's Warning printed by the manufacturer.

Other: Surgeon General's Warning

Interventions

Surgeon General's Warning OTHER

Participants will be randomly assigned to receive warnings with one of the four Surgeon General's Warnings on their cigarette packs for 4 weeks: 1. SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy. 2. SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health. 3. SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight. 4. SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.

Surgeon General's Warning

Graphic Warning OTHER

Participants will be randomly assigned to receive one of the following four graphic warnings on their cigarette packs for 4 weeks: 1. Text: "WARNING: Cigarettes are addictive." Image: Man smoking through tracheotomy hole. 2. Text: "WARNING: Cigarettes causes fatal lung disease." Image: Healthy lungs next to diseased lungs. 3. Text: "WARNING: Cigarettes cause cancer." Image: Mouth with cancerous lesion on lip. 4. Text: "WARNING: Smoking can kill you." Image: Woman dying from cancer.

Graphic Warning

Eligibility Criteria

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

You may qualify if:

• Be 18 years or older
• Have smoked at least 100 cigarettes in his or her lifetime
• Currently smoke cigarettes
• Be able to read and speak English

You may not qualify if:

• Pregnant women
• Smokers who smoke exclusively roll-your-own cigarettes
• Smokers concurrently enrolled in another cessation study
• Smokers who smoke fewer than 7 cigarettes per week, on average
• 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

Study Sites (2)

Prevention Research Center of the Pacific Institute for Research & Evaluation

Oakland, California, 94612, United States

Location

Pacific Institute for Research and Evaluation

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (4)

• Brewer NT, Parada H, Hall MG, Boynton MH, Noar SM, Ribisl KM. Understanding Why Pictorial Cigarette Pack Warnings Increase Quit Attempts. Ann Behav Med. 2019 Mar 1;53(3):232-243. doi: 10.1093/abm/kay032.

  PMID: 29850764 DERIVED

• Parada H Jr, Hall MG, Boynton MH, Brewer NT. Trajectories of Responses to Pictorial Cigarette Pack Warnings. Nicotine Tob Res. 2018 Jun 7;20(7):876-881. doi: 10.1093/ntr/ntx182.

  PMID: 29059340 DERIVED

• Brewer NT, Hall MG, Noar SM, Parada H, Stein-Seroussi A, Bach LE, Hanley S, Ribisl KM. Effect of Pictorial Cigarette Pack Warnings on Changes in Smoking Behavior: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):905-12. doi: 10.1001/jamainternmed.2016.2621.

  PMID: 27273839 DERIVED

• Brewer NT, Hall MG, Lee JG, Peebles K, Noar SM, Ribisl KM. Testing warning messages on smokers' cigarette packages: a standardised protocol. Tob Control. 2016 Mar;25(2):153-9. doi: 10.1136/tobaccocontrol-2014-051661. Epub 2015 Jan 6.

  PMID: 25564282 DERIVED

MeSH Terms

Conditions

Smoking; Cigarette Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking

Study Officials

• Noel Brewer, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 25, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)