Lung CancerPhase 3NCT01782053
Communicating Smoking Risks Through Graphic Warning Labels
A Phase 3 study testing Picture warning in people with Lung Cancer and Heart Disease, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette packs as well as nine new statements of smoking risks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Heart Disease
- What is being tested?
- Picture warning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smoke between 5 and 40 cigarettes per day and 100 in lifetime
- Not currently trying to quit
- between 18 and 65 years of age
Who cannot join
- smokes 120's or roll-your own or noncommercial cigarettes
- pregnant or breastfeeding
- history of substance abuse past 5 years
- more than 25 standard alcohol drinks per week
- use of other nicotine products, such as cigars, nicotine gum
- current treatment for copd, cancer, pulmonary disease, alcohol/drug dependence
Show all 15Show fewer
- current treatment for a psychiatric condition
- physical/visual/mental impairment that prevents reading from a computer screen
- not US resident
- unable to read English
- English not main language
- other member of household in study
- friend who smokes in study
- unable to attend weekly appointments between 9 am and 6 pm Monday-Friday
- unable to use hand-held computer to enter daily mood ratings
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lazenby Hall, Ohio State University
Columbus, Ohio, 43210
Annenberg Public Policy Center
Philadelphia, Pennsylvania, 19104
About this study
Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette packs as well as nine new statements of smoking risks. This trial tests the effectiveness of the warnings proposed by the Food and Drug Administration by providing cigarettes with the proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In addition, the trial tests the effects of different warning label components.
- Conditions
- Lung Cancer, Heart Disease
- Being tested
- Picture warning, Control
- Medical subject headings
- Lung Neoplasms, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picture warningBehavioural
Warning contains picture proposed for each text statement by FDA
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control condition | Experimental | Current packaging with warning on side replaced with one of 9 mandated warning statements Receives: Behavioral: Control |
| Text plus picture | Experimental | Revised packaging with half of front and back of pack showing FDA proposed warning including image. Receives: Behavioral: Picture warning |
| Picture plus additional warning text | Experimental | Same as text plus picture but containing additional text elaborating on the basis for the warning. Receives: Behavioral: Picture warning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to try to quit smoking in next 30 days
Measured: Assessed after 4 weeks of exposure to new labels
Secondary outcomes (1)
Affective reactions toward cigarettes and smoking cues
Measured: After 4 weeks of exposure to the new warning labels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Dan Romer, University of Pennsylvania
- Investigators
- Daniel Romer, PhD, Principal investigator, University of PennsylvaniaEllen Peters, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782053
- Sponsor's protocol ID
- 1R01CA157824-01A1
- Status last verified
- Dec 2014
- First submitted
- 29 Jan 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans AT, Peters E, Strasser AA, Emery LF, Sheerin KM, Romer D. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial. PLoS One. 2015 Dec 16;10(12):e0142879. doi: 10.1371/journal.pone.0142879. eCollection 2015.
PubMed 26672982
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Smoking Risks Through Graphic Warning Labels
- ClinicalTrials.gov ID
- NCT01782053
- Acronym / sponsor ID
- 1R01CA157824-01A1
- Conditions
- Lung Cancer, Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette packs as well as nine new statements of smoking risks. This trial tests the effectiveness of the warnings proposed by the Food and Drug Administration by providing cigarettes with the proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In addition, the trial tests the effects of different warning label components.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control condition | Experimental | Behavioral: ControlCurrent packaging with warning on side replaced with one of 9 mandated warning statements |
| Text plus picture | Experimental | Behavioral: Picture warningRevised packaging with half of front and back of pack showing FDA proposed warning including image. |
| Picture plus additional warning text | Experimental | Behavioral: Picture warningSame as text plus picture but containing additional text elaborating on the basis for the warning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- smoke between 5 and 40 cigarettes per day and 100 in lifetime
- Not currently trying to quit
- between 18 and 65 years of age
Key exclusion criteria (15 listed)
- smokes 120's or roll-your own or noncommercial cigarettes
- pregnant or breastfeeding
- history of substance abuse past 5 years
- more than 25 standard alcohol drinks per week
- use of other nicotine products, such as cigars, nicotine gum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picture warningWarning contains picture proposed for each text statement by FDA | Behavioural | Picture plus additional warning text, Text plus picture |
| Control | Behavioural | Control condition |
Primary outcome
Intention to try to quit smoking in next 30 days
Time frame: Assessed after 4 weeks of exposure to new labels
1 secondary outcome
Affective reactions toward cigarettes and smoking cues
Time frame: After 4 weeks of exposure to the new warning labels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 26672982Evans AT, Peters E, Strasser AA, Emery LF, Sheerin KM, Romer D. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial. PLoS One. 2015 Dec 16;10(12):e0142879. doi: 10.1371/journal.pone.0142879. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Romer, PhD principal investigator
University of Pennsylvania
Ellen Peters, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Picture warning in people with Lung Cancer and Heart Disease, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to try to quit smoking in next 30 days (time frame: Assessed after 4 weeks of exposure to new labels). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.