Communicating Smoking Risks Through Graphic Warning Labels

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01782053

Enrollment

245

Registered

2013-02-01

Start date

2013-01-31

Completion date

2014-04-30

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease, Lung Cancer

Brief 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. 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.

Interventions

BEHAVIORALPicture warning

Warning contains picture proposed for each text statement by FDA

BEHAVIORALControl

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Intention to try to quit smoking in next 30 days	Assessed after 4 weeks of exposure to new labels

Secondary

Measure	Time frame
Affective reactions toward cigarettes and smoking cues	After 4 weeks of exposure to the new warning labels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026