Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01867242 |
Other study ID # |
2012NTLS050 |
Secondary ID |
5U19CA157345 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2013 |
Est. completion date |
May 2018 |
Study information
Verified date |
April 2023 |
Source |
University of Minnesota |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Cigarette smokers who are eligible will enter a Camel Snus sampling phase. Smokers interested
in continuing with the study after the sampling phase will undergo a 2 week baseline
assessment phase and will then be randomized to one of the three experimental conditions for
8 weeks. Tobacco use patterns, subjective responses to product, and nicotine and toxicant
exposure will be assessed.
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 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.