Clinical trial NCT00469079: Health Effects of SLT, Cigarette Smoking, and New Tobacco Products
Official title: Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: Biomarkers
Smoking
Tobacco
Cessation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Drug Abuse (NIDA)
First posted: 2007-05-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of smokeless tobacco (ST) as a substitute for cigarette smoking has been suggested since it is considered by some to be a less harmful tobacco product (Russell, Jarvis and Feyerabend, 1980; Russell et al, 1981; Rodu, 1994). ST does not have the volatile constituents and carbon monoxide (CO) that are found in cigarette smoke. Since ST is not smoked there would be less risk of cardiovascular and lung disease. In addition the harm associated with second hand smoke would be eliminated. Although the health risks are reduced in ST users, they still exist due to the presence of nitrosamines found in ST. A better approach would be to use nicotine replacement that did not contain carcinogens, however the cost of such NRT could be prohibitive especially in third world countries where the rate of smoking is continuing to rise and the per capita income is much lower than in the United States.

Purpose: The goal of this study is to evaluate the health effects of Camel Snus, the new oral tobacco product produced by RJ Reynolds and Taboka, produced by Phillip Morris. These products are pasteurized rather than fermented and contain less moisture to eliminate spitting. They are marketed as an alternative to cigarette smoking.

Detailed description: Cigarette smokers (n=125) will be recruited from the local metropolitan area using multiple media outlets. Subjects who are medically and psychologically healthy will be recruited for the study. Cigarette smokers will be informed of the study over the telephone and asked to answer a brief tobacco use history and medical screening questionnaire. If subjects pass the initial screening for the study, they will be asked to attend an orientation meeting at the Tobacco Use Research Center where the study will be explained in more detail, informed consent will be obtained and a full screening evaluation will occur. This evaluation includes the completion of several comprehensive tobacco use and social history forms and a complete physical and psychological screening.

Subjects will be required to attend the clinic once during Week 1 and once during Week 2 of the study in order to obtain baseline data. At the end of Week 2, cigarette smokers will be randomly assigned to either: 1) quit tobacco use and will be offered the choice of using nicotine gum or lozenge, depending on personal preference (n= 25) or they will be assigned to switch to: 2) Taboka (n=50) or 3) Camel Snus (n=50). Subjects sampled different flavors of the products for 1 week and then used the product for the next 4 weeks. During the four weeks, subjects will be asked to attend weekly clinic visits during which time study data will be collected. After the 4 weeks of study product use, subjects will be required to taper off of the tobacco or nicotine product over the next one week and then cease all tobacco use. Follow-up visits will be conducted 1 week and 11 weeks after completion of the study and outcome measures will be taken at that time. Blood and urine samples will be collected and analyzed for tobacco related toxicants during the treatment period.

Eligibility criteria: Inclusion Criteria:

* Subjects between 18-70 years of age
* Smoking at least 10 cigarettes/day for at least one year
* Good physical and mental health as evidenced by a medical history with no unstable medical conditions.

Exclusion Criteria:

* Uncontrolled chronic disease or condition that requires medical attention during the course of the study
* Contraindications for nicotine replacement products: active ulcers, recent heart attack, heart disease or irregular heart beat, uncontrolled high blood pressure, or medication use that might affect tobacco use
* Current unstable psychiatric diagnoses or persons who currently are adjusting medication dose. (within the last 3 months)
* Subjects with current or recent (within 6 months) alcohol or drug abuse problem
* Other regular tobacco use such as regular cigar or pipe smoking
* Currently using other nicotine replacement products
* Chronic use of any drug that could interact with the study drugs.

Primary outcomes:
measure: Toxicant Exposure by Products
timeFrame: Baseline, 4 weeks
measure: Product Use at Week 4 of Intervention
timeFrame: 4 weeks
measure: Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention.
timeFrame: 12 weeks
Secondary outcomes:
measure: Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week.
timeFrame: Baseline and 1 week
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Tobacco Use Research Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotlyar M, Hertsgaard LA, Lindgren BR, Jensen JA, Carmella SG, Stepanov I, Murphy SE, Hecht SS, Hatsukami DK. Effect of oral snus and medicinal nicotine in smokers on toxicant exposure and withdrawal symptoms: a feasibility study. Cancer Epidemiol Biomarkers Prev. 2011 Jan;20(1):91-100. doi: 10.1158/1055-9965.EPI-10-0349. Epub 2010 Nov 10.