An interventional study of Graphic cigarette warning labels, plain packaging in Tobacco Use, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Georgetown University · Not applicable, Interventional, and Prevention
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Among 311 studies in Tobacco Use with a site in United States — 52 open to participants now, 63 under way, 1 of them phase 3. Tobacco Use · United States.
Among the 311 studies in Tobacco Use with a site in United States, this one is the 71st largest by planned enrollment of the 286 interventional ones that give a count, is one of 4 that started in 2014, is one of 231 with no phase, and was the 105th registered.
421 studies on the registry are indexed under Tobacco Use; 83 are open to participants now.
Browse Tobacco Use studies →52 of the 311 studies in Tobacco Use with a site in United States are open now. Recruiting first, the newest first:
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pennsylvania · Sites in United States
Ages 18+
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 18+ · Women only
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 50 Tobacco Use studies recruiting now, 28 (56%) set no upper age limit and 18 (36%) stop at 75 or younger; 2 take children under 18; 27 take healthy volunteers.
This study: 18 Years to 30 Years · all sexes · no healthy volunteers.
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311 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 22 · Phase 3 10 · Phase 4 9
First in 1992; this study’s year is marked. 4 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 127 across 352 interventional studies indexed under Tobacco Use.
Median enrollment 120 across the 286 interventional studies, 174 across the 24 observational. Of the 232 that completed or were terminated, 82 (35%) have results posted.
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67 of 311 have an industry lead sponsor. The 10 most frequent:
Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Georgetown University has 3 studies filed under Tobacco Use — fewer than ten, so there is no comparison to draw.
30 of the studies in Tobacco Use with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05707871Wake Forest University Health SciencesCardiovascular Effects of Very Low Nicotine Content Cigarettes | 2026-12 |
| NCT07710820RAI Services CompanyA Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers | 2026-12 |
| NCT05445804Johns Hopkins UniversityOral Cannabidiol for Tobacco Cessation | 2026-12-01 |
| NCT07598136RAI Services CompanyA Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers | 2026-12-17 |
| NCT04297592Mayo ClinicAntibiotic Prophylaxis in High-Risk Arthroplasty Patients | 2027-01 |
Add all 30 to your calendar (.ics) → With an account.
Among the 311 studies in Tobacco Use with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.
The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.
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Exclusion Criteria:
Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on branded packages.
Behavioral: Graphic cigarette warning labels, plain packaging
Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on plain or standardized packages.
Behavioral: Graphic cigarette warning labels, plain packaging
Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on branded packages.
Behavioral: Graphic cigarette warning labels, plain packaging
Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on plain or standardized packages.
Behavioral: Graphic cigarette warning labels, plain packaging
Participants assigned to this arm use their regular cigarette packs and complete study measures only.
This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
Cigarette purchase appeal
The effects of graphic cigarette warnings and plain packaging on cigarette purchase appeal will be measured using data collected from a within-subjects experiment at baseline. Participants are randomly assigned to compare each pair of packs from the experimental conditions versus a standard branded control pack. For each pair, cigarette purchase appeal is measured with 5 valid questions assessing: 1) Which pack would you be most likely to buy? 2) Which pack is the most appealing? 3) Which pack attracts your attention? 4) Which pack contains cigarettes that are the most harmful to your health? 5) Which pack makes you think about the health risks of smoking?
Time frame: Baseline
Motivation to quit smoking
Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.
Time frame: At the conclusion of the 4 week exposure
Cigarette smoking behavior
Cigarettes smoked per day is measured using a single valid question assessing about how many cigarettes participants smoked each day, on average.
Time frame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Smoking quit attempts
Attempts to quit smoking is measured using a single valid item asking participants how many times they stopped smoking for 1 day or longer because they were trying to quit.
Time frame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Motivation to quit cigarette smoking.
Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.
Time frame: At 1-month and 3-months post-exposure
Plan to share: Undecided — We will consider requests to share de-identified individual participant data by request and according to our study protocol and institutional data sharing policy.
Ran from Sep 2014 to primary completion in Aug 2020, 71 months.
Of 167 non-industry interventional studies with no phase under Tobacco Use, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 71 months is above that.
Counting every sponsor, half of 223 studies reached it within 16 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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