ClinicalTrials.gg
RecruitingNCT07348679Updated Jun 5, 2026

Cigarette Filter Study

An interventional study of Charcoal filtered cigarettes with marketing and Charcoal filtered cigarette without marketing in Smoking ( Cigarette), sponsored by Rutgers, The State University of New Jersey. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The overall purpose of this study is to determine the effects of using charcoal-filtered cigarettes on product perceptions, smoking behaviors, and biomarkers of exposure to tobacco-related toxicants. The main questions it aims to answer are:

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.

02

Conditions studied

  • Smoking ( Cigarette)

Keywords

  • smoking behavior
  • charcoal
  • cigarette filter
  • perceptions
  • biomarkers
03

In context

Cigarette Smoking

475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.

This study's planned enrollment of 252 is above the median of 96 across 406 interventional studies indexed under Cigarette Smoking.

Browse Cigarette Smoking studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Eligible subjects will be:

    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 , which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

Exclusion criteria

Exclusion Criteria:

  • Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
252 participants (estimated)

Study arms

  • Experimental
    NAS Sky charcoal-filtered cigarettes

    Charcoal-filtered cigarettes

    Behavioral: Charcoal filtered cigarettes with marketing

  • Active comparator
    NAS Yellow non-charcoal-filtered cigarettes

    Conventional-filtered cigarettes

    Behavioral: Non-charcoal filtered cigarettes

  • Experimental
    Tareyton charcoal cigarettes

    Charcoal-filtered cigarettes

    Behavioral: Charcoal filtered cigarette without marketing

Interventions

  • BehavioralCharcoal 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

  • BehavioralCharcoal 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

  • BehavioralNon-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

06

What researchers measure

Primary outcomes

  1. Risk beliefs

    Risk beliefs will be captured via 8 items rated on a 5-point Likert scale (1 = "definitely untrue", 5 = "definitely true") that evaluate participants' preferred brand and the cigarettes they smoke on the following beliefs: a) "lower in nicotine", b) "lower in tar", c) "less addictive", d) "less likely to cause cancer", e) "has fewer chemicals", f) "is healthier", g) "makes smoking safer", h) "helps people quit smoking." Individual items will be scores as correct or incorrect, and incorrect responses will be summed to created an overall false beliefs score (0-8 range, with higher scores indicating greater false beliefs about reduced risk.

    Time frame: Day 35

  2. Perceived health risks

    Participants will indicate on a 7-point Likert scale (1 = "very low risk", 7 = "very high risk") their risk of developing smoking-related health conditions (i.e., lung cancer, heart disease, stroke, emphysema, respiratory infections, and other cancers) from regular use of the cigarette they are smoking. Higher mean scores indicate greater perceived risk (range 1-7).

    Time frame: Day 35

  3. Subjective ratings

    Participants will rate cigarettes smoked during in-person visits using 14 individual items assessing various cigarette characteristics (e.g., strength, taste, satisfaction, harshness) used by the tobacco industry and our laboratory. Items are rated on a 100 mm visual analog scale with item-specific anchors (e.g., strength: 0 = "very weak," 100 = "very strong"); lower scores indicate less favorable ratings. We will examine mean composite scales generated from these items to assess domains of product harshness, smoking satisfaction, positive sensory experience, and cleanliness.

    Time frame: Day 35

  4. Daily cigarette consumption

    Daily cigarette consumption will be assessed by participant self-report and verified through collection of used filters for all cigarettes smoked during the 5-week study. The mean will be computed for daily cigarette consumption during the week preceding final study session (i.e., mean of cigarettes smoked per day between Sessions 5 and 6, or Days 28-35).

    Time frame: Day 35

  5. Smoking topography (puffs taken)

    We will use a validated procedure to score video recorded smoking sessions to quantify puffing behavior to obtain estimated number of puffs taken.

    Time frame: Day 35

  6. Smoking topography (total duration)

    We will use a validated procedure to score video recorded smoking sessions to quantify puffing behavior to obtain estimates of the duration of each puff, and sum these to create a summary composite measure (in sec).

    Time frame: Day 35

  7. Smoking topography (total interpuff interval)

    We will use a validated procedure to score video recorded smoking sessions to quantify puffing behavior to obtain estimates of interpuff interval (i.e., time between puffs) and created a summed composite (in sec).

    Time frame: Day 35

  8. Session onset carbon monoxide (CO)

    CO will be assessed in ppm using the coVita Micro+ pro Smokerlyzer breath CO monitor (Santa Barbara, CA) at session onset to estimate daily tobacco exposure.

    Time frame: Day 35

  9. Carbon monoxide (CO) boost

    CO will be assessed in ppm using the coVita Micro+ pro Smokerlyzer breath CO monitor (Santa Barbara, CA) before and after each cigarette smoked. The change in CO resulting from smoking a cigarette, CO boost, estimates exposure due to smoking an individual cigarette.

    Time frame: Day 35

  10. Tobacco/nicotine exposure

    Total nicotine equivalents exposure will be assessed via measuring urine concentrations of nicotine metabolites by liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) using Waters Xevo® TQ-XS Tandem Mass Spectrometer with ACQUITY UPLC I-Class Chromatography System (UPLC-MS-MS). Greater values indicate greater exposure.

    Time frame: Day 35

  11. NNAL exposure

    We will assess NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol), a metabolite of NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone), a potent lung carcinogen. A highly sensitive UHPLC-MS/MS method with Waters Xevo® TQ-XS UPLC-MS-MS will determine total NNAL in urine using liquid-liquid extraction followed by conversion to the hexanoate ester derivative. Greater values indicate greater exposure.

    Time frame: Day 35

  12. VOC exposure

    We will collect a urine sample to assess exposure to seven volatile organic compounds (VOCs) due to their association with adverse health effects such as cancer, birth defects, and neurological damage S-(3-hydroxypropyl)-mercapturic acid (3HPMA, a metabolite of potentially toxic acrolein; 2-Carbamoyl-2-hydroxy-ethyl mercapturic acid (2CAHEMA, a metabolite of a neurotoxicant acrylamide); 2-carbamoyl-2-hydroxy-ethyl mercapturic acid (2CYEMA, a metabolite of a potent respiratory irritant acrylonitrile); phenyl mercapturic acid (PHMA, a metabolite of IARC Group 1 carcinogen benzene); benzyl mercapturic acid (BZMA, a metabolite of IARC Group 3 carcinogen toluene); 2,4-Dimethylphenyl mercapturic acid (24MPHMA, a metabolite of IARC Group 3 carcinogen xylene); and N-Acetyl-S-(4-hydroxy-2- buten-1-yl)-L-cysteine (MHBMA3, a metabolite of 1,3-Butadiene).

    Time frame: Day 35

Secondary outcomes

  1. End of study interview

    We will conduct in-depth interviews with participants to qualitatively assess their reactions to the cigarettes they used during the experimental period to provide important contextual information to interpret the behavioral and survey outcome results. An interviewer will be trained with and will use an interview guide that includes open-ended questions pertaining to subjective ratings, appeal, and harm perceptions of the different types of cigarettes used in the study, with probes to inquire about associations of specific features (i.e., the charcoal filter) with reduced harm. We will also ask participants about the role of charcoal in other non-tobacco products.

    Time frame: Day 35

  2. Craving

    Craving will be assessed using at session onset using the Questionnaire on Smoking Urges with a "right now" frame of reference to determine a summary score from a 32-item Likert-format self-report instrument; mean scores range from 1-7 with greater scores indicating greater craving.

    Time frame: Day 35

  3. Withdrawal

    The 21-item Withdrawal Symptom Checklist (WSC) using a "right now" frame of reference, will ask participants to rate the intensity of their symptoms (e.g., cravings, irritability, difficulty concentrating) on a 4-point scale (0 = not present, 3 = severe) at session onset.

    Time frame: Day 35

  4. Attitudes

    Attitudes toward study-supplied cigarettes will be assessed by the mean of an eight-item, seven-point semantic differential scale (Strasser, Cappella, et al., 2009; Yzer et al., 2003) that asks, "Which of the words below would best describe your continued use of this product?" Items were a) bad/good, b) unenjoyable/enjoyable, c) unpleasant/pleasant, d) foolish/wise, e) difficult/easy, f) more/less harmful, g) not under/under my control, and h) less/more healthy. Higher scores indicate more favorable attitudes.

    Time frame: Day 35

  5. Intentions

    Two Likert-type items will assess participants' intentions to purchase and regularly use the study-supplied cigarettes, using a 5-point response scale, with greater scores indicating greater intention.

    Time frame: Day 35

  6. Cigarette purchase task

    Behavioral economic indices of demand will be measured using a hypothetical purchase task that asks participants how many study cigarettes they would purchase a day at free price and across a price range guided by our previous work and a scoping review on tobacco demand.

    Time frame: Day 35

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Deidentified raw and deidentified and recoded survey, smoking behavior, biomarker, and interview data will be preserved and shared. Respondent identifiers will not be shared. Raw audio recordings of qualitative interviews and video recordings of smoking sessions will not be shared as these cannot be fully deidentified (e.g., video recordings contain full facial images of participants); however, data derived from these recordings will be shared.

Supporting information: Study protocol, Analytic code

Time frame: IPD and supporting information will be made accessible as soon as possible, and no later than at the time of publication or at the end of the award, whichever comes first. Study data deposited in NAHDAP will be available to the research community in perpetuity.

Access criteria: Deidentified study data will be made available open access without restrictions to the research community via the National Addiction \& HIV Data Archive (NAHDAP). Individuals wishing to access the data must register with NAHDAP and agree to the Terms of Use, which are designed to protect the participants in the sample by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify participants, and requiring immediate reporting of any disclosure of participant identity. Data users also agree not to share or redistribute any data downloads.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Dec 2030, 56 months after the start.

Of 184 non-industry interventional studies with no phase under Cigarette Smoking, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's planned 56 months is above that.

Counting every sponsor, half of 191 studies reached it within 20 months; a quarter within 9 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2026
First posted
Jan 16, 2026
StartActual
Apr 27, 2026
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2030
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07348679
Responsible party
Melissa Mercincavage, PhD (Principal Investigator, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Jan 16, 2026
Start date
Apr 27, 2026
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jun 5, 2026

Study contacts

Matthew Joy, MPH
Contact
maj206@ints.rutgers.edu
848-267-8284
Melissa Mercincavage, PhD
principal investigator · Rutgers, The State University of New Jersey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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