Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

This is a single site, single-blind, randomized trial with three experimental conditions
tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07
nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and
medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco
and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental
cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study
will examine the use of nicotine-containing products across the three experimental
conditions. Subjects will be monitored to determine their continued use of assigned
cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or
non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers,
dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing
products. Toxicant exposure across the three conditions will also be examined.

Eligible subjects will be provided very low nicotine content cigarettes and are told to use
the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics,
smoking and health history, drug and alcohol use history, mood and perceptions of the study
tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and
tobacco-related toxicants.

Inclusion Criteria:

- Male or female subjects who are at least 18 years of age with a history of regular
smoking for at least 1 year and no serious quit attempts in the last 3 months

- No unstable and significant medical or psychiatric conditions, including lack of
stabilization of medications.

- Subject has provided written informed consent to participate in the study

Exclusion Criteria:

- Regular use of tobacco products (including e-cigarettes) other than cigarettes

- Regular use of nicotine replacement or other tobacco cessation products for purpose
of quitting.

- Pregnant or breastfeeding (due to toxic effects from tobacco products).

- Planned quit date within the next two months.

- Does not have a way that the research team can communicate with them by phone or
e-mail.

- Not able to read and write English well enough to complete study activities without
translation.