NCT02974582

Brief Summary

Background: Smoking is a major public health problem in the U.S. Almost a half a million Americans die from it in a year. One thing that contributes to why people smoke is the marketing of cigarettes. Cigarette direct mail marketing usually targets young smokers of lower socioeconomic status. Researchers want to find out more about how this kind of marketing influences smoking behavior in young people from different socioeconomic levels. Objectives: To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal. To study how these things may differ among young adult smokers of high and low socioeconomic status. Eligibility: Volunteer adults ages 18 to 29 who smoke. Design: Participants will have 1 visit. Participants will be asked questions about their health and recent smoking. A nurse will check their vital signs. Participants will have a simple eye exam. They will give blood and urine samples. Participants will be connected to equipment. This will collect data while they look at pictures. Then they will have a 10-minute break. A nurse will observe them during the break. Participants will have their breath analyzed. Participants will answer questions. The topics will include: Education Job Income Family history Tobacco use Exposure to pro-smoking and anti-smoking messages History of drug and alcohol use

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
9.3 years until next milestone

Study Start

First participant enrolled

March 17, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

November 22, 2016

Last Update Submit

March 17, 2026

Conditions

Keywords

CigarettesBehaviorsAttitudesBeliefs

Outcome Measures

Primary Outcomes (2)

  • To collect pilot data to examine the variability in beliefs, affective responses, and arousal between young adult smokers of high and low socioeconomic status.

    Measure of physiological responses.

    1 Day

  • To conduct a randomized comparative trial to examine the effect of cigarette direct mail materials on beliefs, affective responses, arousal, and smoking behavior, and their variation by SES among young adult smokers.

    Measure of physiological responses.

    1 Day

Secondary Outcomes (1)

  • To select cigarette direct mail marketing materials that are perceived to be similar in their persuasiveness for Part 2 of the study.

    1 Day

Study Arms (4)

1/Part 1

EXPERIMENTAL

60 Participants of high and low SES

Behavioral: Exposure to non health related images

2/Part 2 - Discount Coupons

EXPERIMENTAL

Randomized to view direct mail marketing

Behavioral: Exposure to smoking advertising with coupon

3/Part 2 - No Discount Coupons

EXPERIMENTAL

Randomized to view direct mail marketing

Behavioral: Exposure to smoking advertising without coupons

4/Part 2 - Control

EXPERIMENTAL

Randomized to view direct mail marketing

Behavioral: Exposure to non health related images

Interventions

Direct mail marketing of smoking advertising with discount coupon

2/Part 2 - Discount Coupons

Direct mail marketing of smoking advertising without discount coupon

3/Part 2 - No Discount Coupons

Control group

1/Part 14/Part 2 - Control

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 to 29 years, given our focus on young adults.
  • Smoking status: Current smokers who report smoking every day and who have smoked at least 100 cigarettes in their lifetime with a breath carbon monoxide level greater than 6ppm per device guidelines
  • SES: For the purpose of the study, we will use the empirical groups from our analysis of the Current Population Survey -Tobacco Use Supplement data. Two groups are chosen based on their social determinants and prevalence of smoking.
  • Low SES: Young adults who do not have a four-year college degree, are not currently enrolled in a four-year college, were born in the US, and have an annual income less than $50,000. This is the group that has been shown to have the highest prevalence of smoking.
  • High SES: Young adults who are currently enrolled in or graduated from a four year college. This is the group that has been shown to have the lowest prevalence of smoking.
  • English proficiency: since study materials are available only in English, only participants who are able to understand English and follow instructions in English are to be enrolled.
  • Cognitive ability: Able to understand and willing to sign a written informed consent document.
  • General health: Participants need to be generally healthy, as defined as someone with no known significant health problems. Participants can have chronic health conditions if the condition is well managed.

You may not qualify if:

  • Inability, in the judgment of the investigator, to understand and follow the requirements of the protocol.
  • Currently enrolled in high school.
  • Participants with eye conditions that restrict their ability to track an object with their eyes.
  • Participants with myopia, hyperopia, and/or astigmatism who cannot pass a simple vision test even with corrective lenses.
  • Participants with medical condition(s) that may be triggered by infrared radiation (e.g., epilepsy).
  • Self-reported use of alcohol, recreational drugs or prescription medications used for recreational purposes (e.g., amphetamines, cannabis, cocaine, MDMA, ketamines, LSD, opiates and opioids, tranquilizers or opioid analgesics) that may influence their judgement at the time of study in the past 12 hours before the study visit.
  • Participants who cannot see an object located between 15 to 27 inches away from them (the required distance between the computer screen and the participants for accurate eye-tracking), even with corrective contact lenses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Tobacco Use DisorderBehavior

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Tsz Chun Choi, Ph.D.

    National Institute on Minority Health and Health Disparities (NIMHD)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 28, 2016

Study Start

March 17, 2026

Primary Completion

March 17, 2026

Study Completion

March 17, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations