- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02785484
Impact of Cigarette Pack Constituent Disclosures
Randomized Controlled Trial Evaluating the Impact of Cigarette Pack Constituent Disclosures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Federal law requires the U.S. Food and Drug Administration (FDA) to disseminate information about tobacco constituents. The 2009 Family Smoking Prevention and Tobacco Control Act grants FDA broad authority to regulate tobacco products, including helping the public to better understand harmful and potentially harmful constituents (HPHCs) present in tobacco products and tobacco smoke. According to Section 206 of the Act, using the appropriate federal rulemaking channels and procedures, FDA may require disclosure of tobacco constituents if the disclosed information benefits public health and increases consumer awareness of the health consequences of tobacco products. This study will assess the impact of constituent disclosures on smokers' cigarette packs 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 5 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: At the week 2 visit, study personnel will randomly assign participants to one of the two study arms. The investigators will determine the randomization order a priori. Smokers have an equal chance of being randomized to have labels with constituent disclosure messages or labels with litter messages applied to their cigarette packs.
Assessment: Participants will complete 5 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 all 5 visits, participants will complete a survey. At visits 2-4, participants' will have their cigarette packs labeled based on their condition. Cigarette packs will be tracked at all 5 study visits.
Detailed description of the intervention: Each week participants 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 and tracking. Additionally, they will bring in any unused labeled packs from the previous visit when applicable. While participants are taking the survey, research staff will count participants' cigarette packs. Study staff will mark packs with a code indicating the date of the visit and label them.
Participants randomized to the intervention arm will have labels with constituent disclosure messages applied to their cigarette packs during visits for weeks 2-4. Constituent disclosures that include text about chemicals in cigarette smoke and health effects of the chemicals will be applied to participants' cigarette packs as labels 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. Participants assigned to the control arm will have labels with litter messages applied to the right side of their cigarette packs.
The investigators will instruct participants in both arms to smoke or not smoke as they normally would. The investigators will assess how many cigarettes participants smoked from packs previously brought to a visit and other sources to calculate intervention dose (% of cigarettes smoked from labeled packs). At the end of the study, participants will receive a list of cessation resources.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94108
- Ewald & Wasserman Research Consultants, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quit intentions
Time Frame: 4 weeks
|
The primary outcome is quit intentions measured at 4 weeks by survey.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful Quitting
Time Frame: 4 weeks
|
Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.
|
4 weeks
|
Awareness of health effects from smoking cigarettes
Time Frame: 4 weeks
|
Awareness of health effects will be measured at 4 weeks by survey.
|
4 weeks
|
Awareness of cigarette smoke constituents
Time Frame: 4 weeks
|
Awareness of constituents will be measured at 4 weeks by survey.
|
4 weeks
|
Quit attempts
Time Frame: Up to 4 weeks
|
Quit attempt will be measured during the 4 weeks of the study, reported at either 2, 3, or 4 weeks.
A quit attempt is defined as 24 hours without smoking.
|
Up to 4 weeks
|
Forgoing a cigarette
Time Frame: 4 weeks
|
Forgoing a cigarette will be measured at 4 weeks as the frequency of butting out a cigarette or forgoing a cigarette in an effort to smoke less.
|
4 weeks
|
Perceived likelihood
Time Frame: 4 weeks
|
Perceived likelihood of developing smoking-related health outcomes will be measured at 4 weeks by survey.
|
4 weeks
|
Frequency of conversations about health messages
Time Frame: 4 weeks
|
Frequency of conversations with others about the health message on cigarette packs will be measured at 4 weeks by survey.
|
4 weeks
|
Negative affective reactions
Time Frame: 4 weeks
|
Negative affect will be measured at 4 weeks by survey.
|
4 weeks
|
Cognitive elaboration
Time Frame: 4 weeks
|
Cognitive elaboration (how much the participant reports thinking about the label) will be measured at 4 weeks by survey.
|
4 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12-2430
- P50CA180907 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cigarette Smoking Behavior
-
Maastricht University Medical CenterCompletedCigarette Smoking | Cigarette Smoking Toxicity | Smoking BehaviorNetherlands
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); Dana-Farber Cancer Institute; Stanford University and other collaboratorsCompletedCigarette Smoking BehaviorUnited States
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); Dana-Farber Cancer Institute; Stanford University and other collaboratorsCompletedCigarette Smoking BehaviorUnited States
-
Altria Client Services LLCRose Research Center, LLCRecruitingCigarette Smoking BehaviorUnited States
-
Centre for Addiction and Mental HealthCompletedCigarette Smoking BehaviorCanada
-
University of California, Los AngelesPhilip Morris USA, Inc.CompletedCigarette Smoking BehaviorUnited States
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedCigarette Smoking BehaviorUnited States
-
University of PennsylvaniaNational Cancer Institute (NCI); National Institutes of Health (NIH); Food and...CompletedCigarette Smoking BehaviorUnited States
-
University of OklahomaOklahoma Center for the Advancement of Science and TechnologyCompletedTobacco Use Cessation | Tobacco Smoking Behavior | Cigarette Smoking Behavior | Second Hand Tobacco SmokeUnited States
-
Duke UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedSmoking | Cigarette Smoking | Tobacco Smoking BehaviorUnited States
Clinical Trials on Label with constituent disclosure message
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedCigarette Smoking BehaviorUnited States
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)Recruiting
-
University of RochesterNational Institute on Minority Health and Health Disparities (NIMHD)CompletedSmoking CessationUnited States
-
Indiana UniversityPatient-Centered Outcomes Research InstituteCompletedCancer Screening TestsUnited States
-
TalkspaceUniversity of WashingtonActive, not recruitingDepressive Disorder | Study AdherenceUnited States
-
University of Massachusetts, WorcesterPfizer; Reliant Medical GroupCompletedInfluenza | Infections, PneumococcalUnited States
-
University of OklahomaNational Institutes of Health (NIH); National Institute of General Medical...CompletedCOVID-19 | Vaccine RefusalUnited States
-
Penn State UniversityCompletedCardiovascular Risk FactorUnited States
-
Oklahoma State University Center for Health SciencesCompletedSmoking, TobaccoUnited States
-
Aydin Adnan Menderes UniversityCompletedWomen's Health | Premenstrual Syndrome | Physical ExerciseTurkey