Nicotine DependenceNCT02974582
Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
A study testing Exposure to smoking advertising with coupon, Exposure to smoking advertising without coupons and Exposure to non health related images in people with Nicotine Dependence, run by National Institute on Minority Health and Health Disparities (NIMHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Exposure to smoking advertising with coupon, Exposure to smoking advertising without coupons and Exposure to non health related images
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to 17 Mar 2026
- Phase
- Interventional
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Understanding How Cigarette Direct Mail Marketing Influence Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
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.
Read more
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
Read the detailed description
Smoking remains a public health problem in the US, and cigarette marketing has been concluded as one of the causal factors for the epidemic. Previous studies on cigarette direct mail marketing yielded a limited data on mechanisms influencing smoking behavior. Therefore, there is a need for a study that would provide a stronger evidence on how direct mail marketing influences smoking behavior. The proposed study will consist of two parts where pilot data are to be collected in Part 1, and further data are to be collected in Part 2 conducted as a randomized comparative trial. Up to a total of 530 volunteers ages 18-29 are to be recruited for the study. After meeting the eligibility and enrolling onto the study, participants will have their biospecimens collected followed by an experiment in which they are to be shown images on the computer. Study participants will then take a break and afterwards will provide additional sociodemographic and psychosocial information through an audio computer assisted self-administered interview.
- Conditions
- Nicotine Dependence
- Being tested
- Exposure to smoking advertising with coupon, Exposure to smoking advertising without coupons, Exposure to non health related images
- Keywords
- Cigarettes, Behaviors, Attitudes, Beliefs
- Medical subject headings
- Tobacco Use Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to smoking advertising with couponBehavioural
Direct mail marketing of smoking advertising with discount coupon
Exposure to smoking advertising without couponsBehavioural
Direct mail marketing of smoking advertising without discount coupon
Exposure to non health related imagesBehavioural
Control group
| Study group | Role | What they receive |
|---|---|---|
| 1/Part 1 | Experimental | 60 Participants of high and low SES Receives: Behavioral: Exposure to non health related images |
| 2/Part 2 - Discount Coupons | Experimental | Randomized to view direct mail marketing Receives: Behavioral: Exposure to smoking advertising with coupon |
| 3/Part 2 - No Discount Coupons | Experimental | Randomized to view direct mail marketing Receives: Behavioral: Exposure to smoking advertising without coupons |
| 4/Part 2 - Control | Experimental | Randomized to view direct mail marketing Receives: Behavioral: Exposure to non health related images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measure of physiological responses.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start17 Mar 2026
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Why it stopped: Study closed due to staffing, operational, and technical challenges that have prevented study initiation; no participant activities or data collection have occurred.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Minority Health and Health Disparities (NIMHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tsz Chun Choi, Ph.D., Principal investigator, National Institute on Minority Health and Health Disparities (NIMHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974582
- Sponsor's protocol ID
- 170015
- Other IDs
- 17-MD-0015
- Status last verified
- Mar 2026
- First submitted
- 22 Nov 2016
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding How Cigarette Direct Mail Marketing Influence Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
- ClinicalTrials.gov ID
- NCT02974582
- Acronym / sponsor ID
- 170015
- Conditions
- Nicotine Dependence
- Keywords
- Cigarettes, Behaviors, Attitudes, Beliefs
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed due to staffing, operational, and technical challenges that have prevented study initiation; no participant activities or data collection have occurred.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute on Minority Health and Health Disparities (NIMHD)US National Institutes of Health
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 28 Nov 2016 (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.
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
Detailed description
Smoking remains a public health problem in the US, and cigarette marketing has been concluded as one of the causal factors for the epidemic. Previous studies on cigarette direct mail marketing yielded a limited data on mechanisms influencing smoking behavior. Therefore, there is a need for a study that would provide a stronger evidence on how direct mail marketing influences smoking behavior. The proposed study will consist of two parts where pilot data are to be collected in Part 1, and further data are to be collected in Part 2 conducted as a randomized comparative trial. Up to a total of 530 volunteers ages 18-29 are to be recruited for the study. After meeting the eligibility and enrolling onto the study, participants will have their biospecimens collected followed by an experiment in which they are to be shown images on the computer. Study participants will then take a break and afterwards will provide additional sociodemographic and psychosocial information through an audio computer assisted self-administered interview.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1/Part 1 | Experimental | Behavioral: Exposure to non health related images60 Participants of high and low SES |
| 2/Part 2 - Discount Coupons | Experimental | Behavioral: Exposure to smoking advertising with couponRandomized to view direct mail marketing |
| 3/Part 2 - No Discount Coupons | Experimental | Behavioral: Exposure to smoking advertising without couponsRandomized to view direct mail marketing |
| 4/Part 2 - Control | Experimental | Behavioral: Exposure to non health related imagesRandomized to view direct mail marketing |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| Exposure to smoking advertising with couponDirect mail marketing of smoking advertising with discount coupon | Behavioural | 2/Part 2 - Discount Coupons |
| Exposure to smoking advertising without couponsDirect mail marketing of smoking advertising without discount coupon | Behavioural | 3/Part 2 - No Discount Coupons |
| Exposure to non health related imagesControl group | Behavioural | 1/Part 1, 4/Part 2 - Control |
Primary outcome
To collect pilot data to examine the variability in beliefs, affective responses, and arousal between young adult smokers of high and low socioeconomic status.
Time frame: 1 Day
Measure of physiological responses.
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.
Time frame: 1 Day
Measure of physiological responses.
1 secondary outcome
To select cigarette direct mail marketing materials that are perceived to be similar in their persuasiveness for Part 2 of the study.
Time frame: 1 Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Tsz Chun Choi, Ph.D. principal investigator
National Institute on Minority Health and Health Disparities (NIMHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to smoking advertising with coupon, Exposure to smoking advertising without coupons and Exposure to non health related images in people with Nicotine Dependence, run by National Institute on Minority Health and Health Disparities (NIMHD) at 1 site 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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To collect pilot data to examine the variability in beliefs, affective responses, and arousal between young adult smokers of high and low socioeconomic status. (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.