Phase 2
N=130
Health Effects of SLT, Cigarette Smoking, and New Tobacco Products
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00469079 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Toxicant Exposure by Products — 835.3; 782.1; 726.8; 0.157 ng/ml — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nicotine gum and lozenge (Drug); Taboka (Other); Camel Snus (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toxicant Exposure by Products |
835.3; 782.1; 726.8; 0.157; 0.281; 0.296 | 0.002 sig |
| PRIMARY Product Use at Week 4 of Intervention |
7.27; 5.27; 6.76 | 0.05 |
| PRIMARY Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention. |
11; 17; 22; 15; 22; 24 | <0.05 sig |
| SECONDARY Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week. |
2.55; 2.76; 2.62; 8.15; 8.89; 8.61 | > 0.10 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00469079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.