- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02785484
Impact of Cigarette Pack Constituent Disclosures
Randomized Controlled Trial Evaluating the Impact of Cigarette Pack Constituent Disclosures
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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California
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San Francisco, California, Egyesült Államok, 94108
- Ewald & Wasserman Research Consultants, LLC
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: Label with constituent disclosure message
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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.
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Egyéb: Label with litter message
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Quit intentions
Időkeret: 4 weeks
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The primary outcome is quit intentions measured at 4 weeks by survey.
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4 weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Sikeres kilépés
Időkeret: 4 hét
|
A sikeres leszokás az elmúlt 7 nap 0 napján a 4 héten belül önbevallott dohányzásként fogható fel.
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4 hét
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Awareness of health effects from smoking cigarettes
Időkeret: 4 weeks
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Awareness of health effects will be measured at 4 weeks by survey.
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4 weeks
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Awareness of cigarette smoke constituents
Időkeret: 4 weeks
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Awareness of constituents will be measured at 4 weeks by survey.
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4 weeks
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Quit attempts
Időkeret: Up to 4 weeks
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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.
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Up to 4 weeks
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Forgoing a cigarette
Időkeret: 4 weeks
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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.
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4 weeks
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Perceived likelihood
Időkeret: 4 weeks
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Perceived likelihood of developing smoking-related health outcomes will be measured at 4 weeks by survey.
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4 weeks
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Frequency of conversations about health messages
Időkeret: 4 weeks
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Frequency of conversations with others about the health message on cigarette packs will be measured at 4 weeks by survey.
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4 weeks
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Negative affective reactions
Időkeret: 4 weeks
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Negative affect will be measured at 4 weeks by survey.
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4 weeks
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Cognitive elaboration
Időkeret: 4 weeks
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Cognitive elaboration (how much the participant reports thinking about the label) will be measured at 4 weeks by survey.
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4 weeks
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Együttműködők és nyomozók
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- 12-2430
- P50CA180907 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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