Health Effects of SLT, Cigarette Smoking, and New Tobacco Products

NCT ID: NCT00469079

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-02-28

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Nicotine gum or nicotine lozenge; Dosage: 2 or 4 mg; Frequency: Daily; Duration: 5 weeks of use of which 1 week is tapering.

Group Type: ACTIVE_COMPARATOR

Nicotine gum and lozenge

Intervention Type: DRUG

Nicotine replacement

2

Taboka - oral tobacco product Dosage: 0.84 to 1.26 mg free nicotine per g dry weight; Frequency: Daily; Duration: 5 weeks of use of which 1 week is tapering.

Group Type: EXPERIMENTAL

Taboka

Intervention Type: OTHER

smokeless tobacco product

3

Camel Snus - oral tobacco product Dosage: 6.09 to 9.16 mg dry weight; Frequency: Daily; Duration: 5 weeks of use of which 1 week is tapering.

Group Type: EXPERIMENTAL

Camel Snus

Intervention Type: OTHER

smokeless tobacco product

Interventions

Nicotine gum and lozenge

Nicotine replacement

Intervention Type: DRUG

Taboka

smokeless tobacco product

Intervention Type: OTHER

Camel Snus

smokeless tobacco product

Intervention Type: OTHER

Other Intervention Names

Commit, Nicorette

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Tobacco Use Research Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21068204 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17400953

Kotlyar M, Mendoza-Baumgart MI, Li ZZ, et al. Nicotine pharmacokinetics and subjective effects of three potential reduced exposure products, moist snuff and nicotine lozenge. Tob Control 2007;16:138-42.

Other Identifiers

P50DA013333

Identifier Type: NIH

Identifier Source: secondary_id

View Link

010M79961

Identifier Type: -

Identifier Source: org_study_id