Cigarette Filter Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • 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

Treatment groups

252 Participants
are divided into 3 treatment groups
Group A: NAS Sky charcoal-filtered cigarettesExperimental treatment 1 intervention
Group B: NAS Yellow non-charcoal-filtered cigarettesActive comparator 1 intervention
Group C: Tareyton charcoal cigarettesExperimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

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Rutgers, The State University of New Jersey

Lead sponsor

National Cancer Institute (NCI)

Collaborator