PROJECT 4: CLINICAL TRIAL METHODS FOR ASSESSING A TOBACCO PRODUCT Part of "MODELS FOR TOBACCO PRODUCT EVALUATION
Baseline smoking period: Subjects will be required to attend baseline clinic visits during
Week -2 and -1 of the clinical trial phase, and they will record 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 use based on the number of cigarettes smoked per day (if
10-20 cigarettes, use snus every 2 hours for about 8 pouches per day, and if >20 cigarettes
then 12 pouches per day ; 4) partial substitution with ad libitum use of both snus and
cigarettes; and 5) partial substitution with controlled use of snus (paralleling the
instructions for complete substitution condition) and ad libitum smoking. Snus, but not
cigarettes, will be provided to subjects at the clinic visits.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Pattern of Tobacco Use
Rate of use of camel snus and use of cigarettes will be compared between groups.
Dorothy Hatsukami, M.D.
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
|Roswell Park Cancer Center||Buffalo, New York 14263|
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|
|Ohio State University Comprehensive Cancer Center||Columbus, Ohio|