Recruitment

Recruitment Status
Completed
Estimated Enrollment
793

Inclusion Criterias

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);
Daily smoker;
Male or female subjects who are at least 18 years of age;
...
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);
Daily smoker;
Male or female subjects who are at least 18 years of age;
Generally good health;

Exclusion Criterias

Pregnant or breastfeeding (due to toxic effects from tobacco products).
Unable to read for comprehension or completion of study documents.
Unstable health
Pregnant or breastfeeding (due to toxic effects from tobacco products).
Unable to read for comprehension or completion of study documents.
Unstable health

Summary

Conditions
Smoker
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 a...

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 use snus instead ; 3) partial substitution - use of both snus and cigarettes as you like. 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 Criterias

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);
Daily smoker;
Male or female subjects who are at least 18 years of age;
...
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);
Daily smoker;
Male or female subjects who are at least 18 years of age;
Generally good health;

Exclusion Criterias

Pregnant or breastfeeding (due to toxic effects from tobacco products).
Unable to read for comprehension or completion of study documents.
Unstable health
Pregnant or breastfeeding (due to toxic effects from tobacco products).
Unable to read for comprehension or completion of study documents.
Unstable health

Locations

Buffalo, New York, 14263
Minneapolis, Minnesota, 55455
Columbus, Ohio, 43210
Buffalo, New York, 14263
Minneapolis, Minnesota, 55455
Columbus, Ohio, 43210

Tracking Information

NCT #
NCT01867242
Collaborators
Not Provided
Investigators
  • Principal Investigator: Dorothy Hatsukami, M.D. Masonic Cancer Center, University of Minnesota
  • Dorothy Hatsukami, M.D. Masonic Cancer Center, University of Minnesota