Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
252 participants
INTERVENTIONAL
2026-02-15
2030-12-31
Brief Summary
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Do perceptions of cigarettes differ by their filter? Do people smoke charcoal-filtered cigarettes differently than cigarettes with conventional filters, and does this change their exposure to cigarette harms?
Study participants will complete a 5-week laboratory-based, open-label, parallel-design randomized trial. After a baseline period of smoking their preferred brand, participants will smoke charcoal-filtered or non-charcoal-filtered cigarettes for 4 weeks while completing weekly sessions to assess primary outcomes. During weekly sessions, they will smoke two cigarettes in our laboratory, provide urine and carbon monoxide samples, and complete questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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NAS Sky charcoal-filtered cigarettes
Charcoal-filtered cigarettes
Charcoal filtered cigarettes with marketing
After completing a 7-day baseline period of smoking their own preferred brand, participants randomized to the charcoal filtered cigarette with marketing condition will use Natural American Spirit Sky cigarettes for the next 28 days
NAS Yellow non-charcoal-filtered cigarettes
Conventional-filtered cigarettes
Non-charcoal filtered cigarettes
After completing a 7-day baseline period of smoking their own preferred brand, participants randomized to the non-charcoal filtered cigarette condition will use Natural American Spirit Yellow cigarettes for the next 28 days
Tareyton charcoal cigarettes
Charcoal-filtered cigarettes
Charcoal filtered cigarette without marketing
After completing a 7-day baseline period of smoking their own preferred brand, participants randomized to the charcoal filtered cigarette without marketing condition will use Tareyton cigarettes for the next 28 days
Interventions
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Charcoal filtered cigarettes with marketing
After completing a 7-day baseline period of smoking their own preferred brand, participants randomized to the charcoal filtered cigarette with marketing condition will use Natural American Spirit Sky cigarettes for the next 28 days
Charcoal filtered cigarette without marketing
After completing a 7-day baseline period of smoking their own preferred brand, participants randomized to the charcoal filtered cigarette without marketing condition will use Tareyton cigarettes for the next 28 days
Non-charcoal filtered cigarettes
After completing a 7-day baseline period of smoking their own preferred brand, participants randomized to the non-charcoal filtered cigarette condition will use Natural American Spirit Yellow cigarettes for the next 28 days
Eligibility Criteria
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Inclusion Criteria
1. Male and female smokers who are at least 21 years of age and self-report smoking at least 5 cigarettes per day for at least the past 6 months.
2. Smokers of primarily non-menthol cigarettes of brands other than Natural American Spirit.
3. Not currently undergoing smoking cessation treatment or trying to quit.
4. Able to communicate fluently in English (speaking, writing, and reading).
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Exclusion Criteria
Smoking Behavior
1. Use of menthol or Natural American Spirit cigarettes as preferred/regular brand (defined as using \>20% of the time).
2. Enrollment or plans to enroll in a smoking cessation program in the next month.
3. Provide an initial Carbon Monoxide (CO) reading \< 5 parts per million (ppm).
Alcohol/Drugs
1. History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
2. Current alcohol consumption that exceeds 25 standard drinks/week.
Medical
1. Women who are pregnant, planning a pregnancy, and/or lactating.
2. Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the PI and eligibility will be determined on a case-by-case basis.
3. Color blindness.
4. Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.
Psychiatric
As determined by self-report:
1. Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
2. Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible.
Other
Additionally, participants may be deemed ineligible for any of the following general reasons at any point throughout the study, as well as during the initial telephone screen, at the discretion of the PI:
* Significant non-compliance with protocol and/or study design.
* Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact study data.
* Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance.
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Melissa Mercincavage, PhD
Principal Investigator
Principal Investigators
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Melissa Mercincavage, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers, The State University of New Jersey
Locations
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Institute for Nicotine and Tobacco Studies
New Brunswick, New Jersey, United States
Countries
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Central Contacts
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Other Identifiers
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Pro2025000854
Identifier Type: -
Identifier Source: org_study_id
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