Addiction Potential of Very Low Nicotine Filtered Little Cigars

Обзор

The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question\[s\] it aims to answer are: Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will * fill several surveys * provide blood samples * perform breathing tests * complete smoking sessions using either their own cigars or the study cigars.

Вмешательства

• Препарат Reduced Nicotine Content Cigars
  Participants will smoke a very low nicotine content filtered little cigar containing 0.50mg nicotine per gram of tobacco
• Препарат Normal nicotine content cigar
  Participants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco
• Препарат Usual brand cigar
  Participants will smoke their usual brand filtered little cigar

Первичные конечные точки

• Drug self-administration- Puff topography- total puff volume [Срок оценки: During session 65 minute puffing session]
• Forced expiratory volume in 1 second [Срок оценки: Change from 0 to 65 minutes]
• Nicotine [Срок оценки: Change from 0 to 5 minutes]
• Nicotine [Срок оценки: Change from 0 to 65 minutes]
• Carbon monoxide boost [Срок оценки: Change from 0 to 5 minutes]
• Carbon monoxide boost [Срок оценки: Change from 0 to 65 minutes]

Вторичные конечные точки (10)

• Functional residual capacity [Срок оценки: Change from 0 to 65 minutes]
• Airway resistance (R5) [Срок оценки: Change from 0 to 65 minutes]
• Airway resistance (R5-R20) [Срок оценки: Change from 0 to 65 minutes]
• Modified Cigarette Evaluation Scale [Срок оценки: 65 minutes]
• Questionnaire on Smoking Urges (Tiffany Drobes) [Срок оценки: Change from 0 to 5 minutes]
• Questionnaire on Smoking Urges (Tiffany Drobes) [Срок оценки: Change from 0 to 65 minutes]
• Minnesota Nicotine Withdrawal Scale [Срок оценки: Change from 0 to 5 minutes]
• Minnesota Nicotine Withdrawal Scale [Срок оценки: Change from 0 to 65 minutes]
• Hypothetical purchase task [Срок оценки: 65 minutes]
• Cross-price task [Срок оценки: 65 minutes]

Критерии участия

Критерии включения

• Smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use will be defined as >=8 cigars smoked per month based on data showing median cigarillo use is 7.5 times per month and median FLC use is 14 times per month 59. We will attempt to bring in heavier users if feasible during recruitment; or 2) Cigarette smokers (>=8d/month for at least 3 months) with either (i) co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in their lifetime) or (ii) answering "yes" to the question "If all cigarettes were taken off the market, would you consider switching to filtered little cigars?"
• willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
• Willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study visit
• capable of and willing to provide written informed consent
• read and speak in English.

Критерии исключения

• Self-reported significant current lung disease (e.g. asthma, COPD, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies for which a patient takes inhalers are allowed
• History of diagnosis or treatment for lung cancer
• Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes)
• History of cardiac event or distress within the past 3 months
• Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
• Substance use disorders besides nicotine addiction
• Regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes >10d per month
• Exclusive large or premium cigar users
• Use of blunts every time or most of the time
• Regular use of cannabis >10d per month
• Planning to quit in next 30 days or currently trying to quit or quit attempt in past 30 days
• Pregnant, delivery in past 12 weeks, breastfeeding, or planning to get pregnant
• Inability to perform tests or follow instructions during testing

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• The Ohio State University — Columbus

Идентификаторы

NCT: NCT06630728 · 2024C0053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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