Clinical trial NCT01867242: Methods Project 4: Clinical Trial
Official title: PROJECT 4: CLINICAL TRIAL METHODS FOR ASSESSING A TOBACCO PRODUCT Part of "MODELS FOR TOBACCO PRODUCT EVALUATION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoker
Keywords: cigarette
snus
smoking
tobacco
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Smoke-free Days
timeFrame: 8 weeks (56 (+/-5) days)
Secondary outcomes:
measure: CEMA (2-cyanoethylmercapturic Acid)
timeFrame: 8 weeks
measure: Total Nicotine Exposure
timeFrame: 8 weeks
measure: Urinary Total NNAL
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Dorothy Hatsukami, M.D.
role: PRINCIPAL_INVESTIGATOR
References: