Health Effects of SLT, Cigarette Smoking, and New Tobacco Products (ANTS3)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence |
Drug: Nicotine gum and lozenge Other: Camel Snus Other: Taboka |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction |
- Toxicant exposure by products [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Abstinence from cigarettes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Abstinence from tobacco [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Nicotine withdrawal symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Respiratory symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Nicotine gum or nicotine lozenge
|
Drug: Nicotine gum and lozenge
Nicotine replacement
Other Name: Commit, Nicorette
|
|
Experimental: 2
Taboka - oral tobacco product
|
Other: Camel Snus
smokeless tobacco product
|
|
Experimental: 3
Camel Snus - oral tobacco product
|
Other: Taboka
smokeless tobacco product
|
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 (cigarette smokers 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. 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Minnesota | |
| Tobacco Use Research Center | |
| Minneapolis, Minnesota, United States, 55414 | |
| Principal Investigator: | Dorothy Hatsukami, PHD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided by National Institute on Drug Abuse (NIDA)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dorothy Hatsukami, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00469079 History of Changes |
| Other Study ID Numbers: | P50 DA013333 |
| Study First Received: | May 3, 2007 |
| Last Updated: | December 9, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Biomarkers Smoking Tobacco Cessation |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Substance-Related Disorders Mental Disorders Habits Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013