Clinical trial NCT02247908: Impact of Graphic Cigarette Warnings
Official title: A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Cigarette smoking
Smoke
Smoking
Tobacco Use
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-25
Enrollment: 2149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The U.S. Food and Drug Administration (FDA) proposed 9 new graphic warnings for cigarette packs in June 2011 to comply with the Family Smoking Prevention and Tobacco Control Act. However, tobacco industry litigation has delayed implementation of graphic warnings. A court ruling that struck down the labels criticized FDA for failing to "present any data - much less the substantial evidence required under the federal law - showing that enacting their proposed graphic warnings will accomplish the agency's stated objective of reducing smoking rates." This study will address this critique head-on by rigorously testing the impact of the graphic warnings on quit attempts in a randomized control trial.

Recruitment: Smokers will first undergo screening online or call the study center to complete the screening questionnaire over the phone. Study staff will schedule eligible smokers for 5 in-person visits. For each of their first 4 visits, smokers will be asked to bring the number of cigarettes they expect to smoke in an 8 day period.

Informed Consent: Prior to consenting smokers, research staff will visually inspect photo identification of smokers who report or appear to be under age 27. At the beginning of the first appointment, study personnel will explain the consent form and ask the smoker to read the form. Once the participant has finished reading the form, the study personnel member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form.

Randomization: After smokers have consented to participating in the study, study personnel will randomly assign them to a condition. The investigators will determine the randomization order a priori. Smokers have an equal chance of being randomized to receive one of four graphic warnings or one of four Surgeon General's warnings. They will receive the same warning on their packs during the study.

Assessment: Participants will complete 6 computer-based surveys during the study. The first appointment will take around 60 minutes and each subsequent visit will take around 30-45 minutes to complete. At their first visit, they will complete a "baseline pre-test," after which study personnel will show participants one of their cigarette packs with the assigned warning. Participants will be allowed to examine the pack. They will then return the pack to the study personnel and complete a "baseline post-test." At the next 3 appointments, participants will complete only one survey and their packs will be labeled. At the final appointment, they will only complete a survey.

Detailed description of the intervention: While participants are taking the survey, research staff will apply study warning labels to participants' cigarette packs during the first 4 visits. Participants assigned to the graphic warning condition will receive one of four graphic warning labels that will be applied and cover the top half of the front and back of their cigarette packs. The text for the graphic warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA. Participants in the Surgeon General's warning condition will receive one of four Surgeon General's Warnings that will be placed on the side of their packs on top of the Surgeon General's warning printed by the manufacturer. This procedure for the control condition is intended to control for the effects of labeling. The investigators will instruct participants in both conditions to use cigarettes from these labeled packs while they are in the study. Each week they will bring in 8 days' of cigarettes (one extra day to provide a buffer in case of rescheduled appointments or smoking more than anticipated) for labeling. Additionally, they will bring in any unused labeled packs from the previous appointment. The investigators will assess how many cigarettes participants smoke from labeled (i.e., study) and unlabeled (i.e., non-study) packs to calculate intervention dose (% of cigarettes smoked from labeled packs). At the end of the study, participants will receive a list of cessation resources. During the final appointment, participants will also report whether they knew anyone else in the study or saw another participant's labels, to assess potential contamination.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quit attempts
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Change in quit intentions
timeFrame: 4 weeks
measure: Successful Quitting
timeFrame: 4 weeks
measure: Change in forgoing a cigarette
timeFrame: 4 weeks
measure: Change in positive reinforcement attitudes
timeFrame: 4 weeks
measure: Change in negative reinforcement attitudes
timeFrame: 4 weeks
measure: Change in perceived likelihood
timeFrame: 4 weeks
measure: Change in frequency of conversations about warning labels
timeFrame: 4 weeks
measure: Fear
timeFrame: 4 weeks
measure: Cognitive elaboration
timeFrame: 4 weeks
Other outcomes:
measure: Change in smoking quantity
timeFrame: 4 weeks
measure: Change in cessation aid use
timeFrame: 4 weeks
measure: Change in e-cigarette use frequency
timeFrame: 4 weeks
measure: Initiation of e-cigarette use
timeFrame: 4 weeks
measure: Change in quit stage
timeFrame: 4 weeks
measure: Change in implementation intentions
timeFrame: 4 weeks
measure: Change in perceived severity
timeFrame: 4 weeks
measure: Change in anticipated regret
timeFrame: 4 weeks
measure: Change in costs of quitting
timeFrame: 4 weeks
measure: Change in benefits of quitting
timeFrame: 4 weeks
measure: Change in response efficacy
timeFrame: 4 weeks
measure: Change in smoking cons
timeFrame: 4 weeks
measure: Change in worry
timeFrame: 4 weeks
measure: Change in self-efficacy to quit smoking
timeFrame: 4 weeks
measure: Change in pack attitudes
timeFrame: 4 weeks
measure: Change in smoker prototypes
timeFrame: 4 weeks
measure: Change in e-cigarette user prototypes
timeFrame: 4 weeks
measure: Change in subjective norms
timeFrame: 4 weeks
measure: Social reactions
timeFrame: 4 weeks
measure: Perceived effectiveness
timeFrame: 4 weeks
measure: Avoidance
timeFrame: 4 weeks
measure: Reactance
timeFrame: 4 weeks
measure: Emotional reactions
timeFrame: 4 weeks
measure: Perceived understandability
timeFrame: 4 weeks
measure: Attention/noticing
timeFrame: 4 weeks
measure: Recall
timeFrame: 4 weeks
measure: Recognition
timeFrame: 4 weeks
Locations:
city: Oakland
country: United States
facility: Prevention Research Center of the Pacific Institute for Research & Evaluation
state: California
city: Chapel Hill
country: United States
facility: Pacific Institute for Research and Evaluation
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Noel Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.