Cigarette Filter Study

Официальное название

A Randomized Trial of Charcoal-filtered Cigarettes on Product Perceptions, Smoking Behaviors, and Toxicant Exposure

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Risk beliefs [Срок оценки: Day 35]
• Perceived health risks [Срок оценки: Day 35]
• Subjective ratings [Срок оценки: Day 35]
• Daily cigarette consumption [Срок оценки: Day 35]
• Smoking topography (puffs taken) [Срок оценки: Day 35]
• Smoking topography (total duration) [Срок оценки: Day 35]
• Smoking topography (total interpuff interval) [Срок оценки: Day 35]
• Session onset carbon monoxide (CO) [Срок оценки: Day 35]
• Carbon monoxide (CO) boost [Срок оценки: Day 35]
• Tobacco/nicotine exposure [Срок оценки: Day 35]

Вторичные конечные точки (6)

• End of study interview [Срок оценки: Day 35]
• Craving [Срок оценки: Day 35]
• Withdrawal [Срок оценки: Day 35]
• Attitudes [Срок оценки: Day 35]
• Intentions [Срок оценки: Day 35]
• Cigarette purchase task [Срок оценки: Day 35]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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:

• Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Institute for Nicotine and Tobacco Studies — New Brunswick

Идентификаторы

NCT: NCT07348679 · Pro2025000854 · R37CA296976

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗