PROJECT 4: CLINICAL TRIAL METHODS FOR ASSESSING A TOBACCO PRODUCT Part of "MODELS FOR TOBACCO PRODUCT EVALUATION
18 Years
N/A
Both
Smoker
Trial Information
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.
Inclusion Criteria:
- Male or female subjects who are at least 18 years of age;
- smoking history of at least 10 cigarettes daily (Carbon Monoxide>8 or NicAlert >2)
for at least 1 year and no serious quit attempts in the last 3 months (to ensure
stability of smoking, particularly for those randomized to the continued smoking
group);
- No unstable and significant medical or psychiatric conditions as determined by
medical history and Prime-MD questionnaire (to ensure safety of the subject, to
minimize the effects of poor health on biomarker measures and to maximize compliance
to study procedures);
- Lack of stabilization of medications (determined by study MD);
- 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:
- Immune system disorders, respiratory diseases, kidney or liver diseases or any other
medical disorders that may affect biomarker data;
- Current or recent alcohol or drug abuse problems (to ensure alcohol and drug use does
not affect biomarkers o nnf exposure and to maximize retention);
- Regular tobacco use (e.g., greater than weekly or 9 times in last 30 days) other than
cigarettes;
- Currently using nicotine replacement or other tobacco cessation products (to minimize
confounding effects of another product) or intention to quit in next three months;
- Pregnant or breastfeeding (due to toxic effects from tobacco products).
- Unable to read for comprehension or completion of study documents.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Pattern of Tobacco Use
Outcome Description:
Rate of use of camel snus and use of cigarettes will be compared between groups.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Dorothy Hatsukami, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2012NTLS050
NCT ID:
NCT01867242
Start Date:
June 2013
Completion Date:
January 2017
Related Keywords:
- Smoker
- cigarette
- snus
- smoking
- tobacco
Name | Location |
|---|---|
| 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 |
