Cigarette Filter Study

Rutgers The State University of New Jersey

Status: Begins enrollment this month

Conditions: Smoking ( Cigarette)

Treatments: Behavioral: Charcoal filtered cigarettes with marketing; Behavioral: Non-charcoal filtered cigarettes; Behavioral: Charcoal filtered cigarette without marketing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07348679

R37CA296976 (U.S. NIH Grant/Contract)

Pro2025000854

Details and patient eligibility

About

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.

Enrollment: 252 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 3 patient groups

NAS Sky charcoal-filtered cigarettes

Experimental group

Description:

Charcoal-filtered cigarettes

Treatment:

Behavioral: Charcoal filtered cigarettes with marketing

NAS Yellow non-charcoal-filtered cigarettes

Active Comparator group

Description:

Conventional-filtered cigarettes

Treatment:

Behavioral: Non-charcoal filtered cigarettes

Tareyton charcoal cigarettes

Experimental group

Description:

Charcoal-filtered cigarettes

Treatment:

Behavioral: Charcoal filtered cigarette without marketing