Official Title: “Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction”

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 tar 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 and salt to eliminate spitting. They will be marketed as an alternative to cigarette smoking.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Cigarette smokers (n=125) and ST users (n=25) 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 and ST users 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 (cigarette smokers and ST users will attend separate orientations) 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 either be randomly assigned to: 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) Camel Snus (n=50) or 3) Taboka (n=50) for 4 weeks. ST users will either be randomly assigned to quit ST and they will be given nicotine polacrilex (choice of gum or lozenge) (n=5) or they will be assigned Camel Snus (n=20) for 4 weeks. During the next 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 two weeks and then cease all tobacco use by week 9. Withdrawal symptoms will be assessed at Week 8, and for the first week following cessation. Follow-up visits will be conducted 1 week (Week 9) and 12 weeks (Week 19) 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.

Intervention(s) in this Clinical Trial

• Drug: Nicotine gum and lozenge
  • Nicotine replacement
• Other: Camel Snus
  • smokeless tobacco product
• Other: Taboka
  • smokeless tobacco product

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Nicotine gum or nicotine lozenge
• Experimental: 2
  • Taboka - oral tobacco product
• Experimental: 3
  • Camel Snus - oral tobacco product

Primary Measures

• Toxicant exposure by products
  • Time Frame: 4 weeks
    Safety Issue?: Yes
• Abstinence from cigarettes
  • Time Frame: 12 weeks
    Safety Issue?: No
• Abstinence from tobacco
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Nicotine withdrawal symptoms
  • Time Frame: 8 weeks
    Safety Issue?: No
• Respiratory symptoms
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• Subjects between 18-65 years of age
• Smoking at least 15 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Dorothy Hatsukami, PHD Principal Investigator University of Minnesota  

Overall Contact: Joni Jensen, MPH 612-627-4903 jense010@umn.edu

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469079

Study ID Number: NIDA-13333

ClinicalTrials.gov Identifier: NCT00469079

Health Authority: United States: Federal Government