Cigarette Filter Study

NCT07348679 | Recruiting

• 2 other identifiers: Pro2025000854R37CA296976
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking ( Cigarette)

Keywords

smoking behavior; charcoal; cigarette filter; perceptions; biomarkers

Outcome Measures

Primary Outcomes (12)

• 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.

  Day 35

• 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).

  Day 35

• 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.

  Day 35

• 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).

  Day 35

• 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.

  Day 35

• 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).

  Day 35

• 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).

  Day 35

• 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.

  Day 35

• 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.

  Day 35

• 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.

  Day 35

• 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.

  Day 35

• 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).

  Day 35

Secondary Outcomes (6)

• End of study interview

  Day 35

• Craving

  Day 35

• Withdrawal

  Day 35

• Attitudes

  Day 35

• Intentions

  Day 35

Study Arms (3)

NAS Sky charcoal-filtered cigarettes

EXPERIMENTAL

Charcoal-filtered cigarettes

Behavioral: Charcoal filtered cigarettes with marketing

NAS Yellow non-charcoal-filtered cigarettes

ACTIVE COMPARATOR

Conventional-filtered cigarettes

Behavioral: Non-charcoal filtered cigarettes

Tareyton charcoal cigarettes

EXPERIMENTAL

Charcoal-filtered cigarettes

Behavioral: Charcoal filtered cigarette without marketing

Interventions

Charcoal filtered cigarette without marketing BEHAVIORAL

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

Tareyton charcoal cigarettes

Non-charcoal filtered cigarettes BEHAVIORAL

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

NAS Yellow non-charcoal-filtered cigarettes

Charcoal filtered cigarettes with marketing BEHAVIORAL

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 Sky charcoal-filtered cigarettes

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects will be:
• 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.
• Smokers of primarily non-menthol cigarettes of brands other than Natural American Spirit.
• Not currently undergoing smoking cessation treatment or trying to quit.
• Able to communicate fluently in English (speaking, writing, and reading).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

You may not qualify if:

• Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:
• Smoking Behavior
• Use of menthol or Natural American Spirit cigarettes as preferred/regular brand (defined as using \>20% of the time).
• Enrollment or plans to enroll in a smoking cessation program in the next month.
• Provide an initial Carbon Monoxide (CO) reading \< 5 parts per million (ppm).
• Alcohol/Drugs
• History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Medical
• Women who are pregnant, planning a pregnancy, and/or lactating.
• 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.
• Color blindness.
• 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:

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Institute for Nicotine and Tobacco Studies

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Anthrax

Interventions

Marketing

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Commerce; Technology, Industry, and Agriculture

Study Officials

• Melissa Mercincavage, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Joy, MPH

CONTACT

848-267-8284; maj206@ints.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 16, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)