Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction

Trial Information

Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction

Cigarette smokers (n=125) will be recruited from the local metropolitan area using multiple
media outlets. Subjects who are medically and psychologically healthy will be recruited for
the study. Cigarette smokers will be informed of the study over the telephone and asked to
answer a brief tobacco use history and medical screening questionnaire. If subjects pass
the initial screening for the study, they will be asked to attend an orientation meeting
(cigarette smokers will attend separate orientations) at the Tobacco Use Research Center
where the study will be explained in more detail, informed consent will be obtained and a
full screening evaluation will occur. This evaluation includes the completion of several
comprehensive tobacco use and social history forms and a complete physical and psychological
screening.

Subjects will be required to attend the clinic once during Week 1 and once during Week 2 of
the study in order to obtain baseline data. At the end of Week 2, cigarette smokers will
either be randomly assigned to: 1) quit tobacco use and will be offered the choice of using
nicotine gum or lozenge, depending on personal preference (n= 25) or they will be assigned
to switch to: 2) Camel Snus (n=50) or 3) Taboka (n=50) for 4 weeks. During the next four
weeks, subjects will be asked to attend weekly clinic visits during which time study data
will be collected. After the 4 weeks of study product use, subjects will be required to
taper off of the tobacco or nicotine product over the next two weeks and then cease all
tobacco use by week 9. Withdrawal symptoms will be assessed at Week 8, and for the first
week following cessation. Follow-up visits will be conducted 1 week (Week 9) and 12 weeks
(Week 19) after completion of the study and outcome measures will be taken at that time.
Blood and urine samples will be collected and analyzed for tobacco related toxicants.