Clinical trial · Interventional
Communicating Smoking Risks Through Graphic Warning Labels
NCT01782053CI-TRIAL-00016197completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heart Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Behavioral | — | UNRESOLVED |
| Picture warning | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Control condition
- description
- Current packaging with warning on side replaced with one of 9 mandated warning statements
- interventionNames
- Behavioral: Control
- type
- EXPERIMENTAL
- label
- Text plus picture
- description
- Revised packaging with half of front and back of pack showing FDA proposed warning including image.
- interventionNames
- Behavioral: Picture warning
- type
- EXPERIMENTAL
- label
- Picture plus additional warning text
- description
- Same as text plus picture but containing additional text elaborating on the basis for the warning.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * smoke between 5 and 40 cigarettes per day and 100 in lifetime * Not currently trying to quit * between 18 and 65 years of age Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDEvans 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. PMID 26672982