Methods Project 4: Clinical Trial

Baseline smoking period: Subjects will be required to attend 2 baseline clinic visits where
baseline assessments will be captured including a record of their cigarette or other tobacco
intake on a daily basis using an interactive voice response system (IVR).

Experimental Period: After the baseline assessment, subjects will be randomized to one of
five experimental conditions: 1) smoking usual brand cigarette controls, who after 8-weeks
will be offered Camel Snus to use as they will for 8 more weeks; 2) complete substitution
(i.e., no smoking) and ad libitum use of snus; 3) complete substitution (i.e., no smoking)
and specific instructions for snus; 4) partial substitution with ad libitum use of both snus
and cigarettes; and 5) partial substitution with controlled use of snus and ad libitum
smoking. Snus, but not cigarettes, will be provided to subjects at the clinic visits.
Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and
biomarker data will be collected.

Inclusion Criteria:

- Male or female subjects who are at least 18 years of age;

- Daily smoker;

- Generally good health;

- Subject has provided written informed consent to participate in the study
(adolescents under the age of 18 will be excluded because this project involves
continued use of tobacco products and new tobacco products);

Exclusion Criteria:

- Unstable health

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

- Unable to read for comprehension or completion of study documents.