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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NAS Sky charcoal-filtered cigarettes 		Charcoal-filtered cigarettes
  • Behavioral: 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
Active Comparator
NAS Yellow non-charcoal-filtered cigarettes 		Conventional-filtered cigarettes
  • Behavioral: 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
Experimental
Tareyton charcoal cigarettes 		Charcoal-filtered cigarettes
  • Behavioral: 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

Recruiting Locations

Institute for Nicotine and Tobacco Studies
New Brunswick, New Jersey 08901
Contact:
Matthew Joy
848-267-4444
filterstudy@ints.rutgers.edu

More Details

Status
Recruiting
Sponsor
Rutgers, The State University of New Jersey

Study Contact

Matthew Joy, MPH
848-267-8284
maj206@ints.rutgers.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.